(265 days)
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
The subject device, Cholangioscope Visualization System, comprises two components: the Single-use Video Cholangioscope and the Full HD Visualization Endoscopic Image Processor.
The Single-use Video Cholangioscope is a single use sterile device. It is composed of working channel, control wheel, operation section, insertion section (integrated with a video image sensor and lighting components), plug section, connection cable, water supply channel, suction channel and accessory- irrigation valve.
The operation section allows users to connect and operate the product. It includes two control wheels (large/small control wheel) to control the bending section at the insertion section to bend in four directions, a lock mechanism can be rotated clockwise to lock the control wheel in its current position, a working channel port can be used for inserting accessories and suction, a bundle mechanism is used to fix the Single-use Video Cholangioscope to the duodenoscope, a water supply port for connecting to the water supply tube, a suction port for connecting to suction tube with a flow control value, and a plug section for connecting with the image processor.
The insertion section can be inserted in patient entirely, and it includes a bending section and a distal end. The bending section can be bent >=50 degrees in four directions by the control wheel. The distal end includes a miniature Complementary Metal Oxide Semiconductor (CMOS) camera, two light-emitting diode (LED) illumination module, two water supply channels for inserting accessories and one working channel for discharging liquid to the suction tube.
The accessory-irrigation value can be connected to the working channel port to expand the working channel, and provide an injection-suction dual-purpose port that can be used for liquid supply or suction through the working channel.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images within the field of view from the body cavity on its LCD display and/or external monitor. The Full HD Visualization Endoscopic Image Processor has four models, they have the same hardware and the difference is mainly in the image adjustment functions.
N/A
FDA 510(k) Clearance Letter - Cholangioscope Visualization System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 20, 2026
Scivita Medical Technology Co.,Ltd.
Jiang Dan
Senior Regulatory Affairs Specialist
No.2, Qingqiu Street, Suzhou Industrial Park
Suzhou, Jiangsu Prov 215000
China
Re: K251338
Trade/Device Name: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCVP-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVSS300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FBN, FET
Dated: December 19, 2025
Received: December 19, 2025
Dear Jiang Dan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. FOOD & DRUG ADMINISTRATION
January 20, 2026
Scivita Medical Technology Co.,Ltd.
Jiang Dan
Senior Regulatory Affairs Specialist
No.2, Qingqiu Street, Suzhou Industrial Park
Suzhou, Jiangsu Prov 215000
China
Re: K251338
Trade/Device Name: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FBN, FET
Dated: December 19, 2025
Received: December 19, 2025
Dear Jiang Dan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251338 - Jiang Dan Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K251338 - Jiang Dan Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
SHANIL P. HAUGEN -S
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251338
Device Name
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Indications for Use (Describe)
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251338
Device Name
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Indications for Use (Describe)
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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K251338 Page 1 of 3
510(k) Summary
510(k)#: K251338
Prepared on: 2026-01-16
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | Scivita Medical Technology Co.,Ltd. |
| Applicant Address | No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou 215000 China |
| Applicant Contact Telephone | 86-512-81877788 |
| Applicant Contact | Wu Ruqin |
| Applicant Contact Email | wuruqin@scivitamedical.com |
| Correspondent Name | Scivita Medical Technology Co.,Ltd. |
| Correspondent Address | No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou Suzhou 215000 China |
| Correspondent Contact Telephone | 86-512-81877788 |
| Correspondent Contact | Jiang Dan |
| Correspondent Contact Email | ra@scivitamedical.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) |
| Common Name | Endoscope and accessories |
| Classification Name | Choledochoscope And Accessories, Flexible/Rigid |
| Regulation Number | 876.1500 |
| Product Code(s) | FBN, FET |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K183636 | SpyScope DS II Access and Delivery Catheter | FBN |
Device Description Summary
21 CFR 807.92(a)(4)
The subject device, Cholangioscope Visualization System, comprises two components: the Single-use Video Cholangioscope and the Full HD Visualization Endoscopic Image Processor.
The Single-use Video Cholangioscope is a single use sterile device. It is composed of working channel, control wheel, operation section, insertion section (integrated with a video image sensor and lighting components), plug section, connection cable, water supply channel, suction channel and accessory- irrigation valve.
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K251338 Page 2 of 3
The operation section allows users to connect and operate the product. It includes two control wheels (large/small control wheel) to control the bending section at the insertion section to bend in four directions, a lock mechanism can be rotated clockwise to lock the control wheel in its current position, a working channel port can be used for inserting accessories and suction, a bundle mechanism is used to fix the Single-use Video Cholangioscope to the duodenoscope, a water supply port for connecting to the water supply tube, a suction port for connecting to suction tube with a flow control value, and a plug section for connecting with the image processor.
The insertion section can be inserted in patient entirely, and it includes a bending section and a distal end. The bending section can be bent ≥50° in four directions by the control wheel. The distal end includes a miniature Complementary Metal Oxide Semiconductor (CMOS) camera, two light-emitting diode (LED) illumination module, two water supply channels for inserting accessories and one working channel for discharging liquid to the suction tube.
The accessory-irrigation value can be connected to the working channel port to expand the working channel, and provide an injection-suction dual-purpose port that can be used for liquid supply or suction through the working channel.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images within the field of view from the body cavity on its LCD display and/or external monitor. The Full HD Visualization Endoscopic Image Processor has four models, they have the same hardware and the difference is mainly in the image adjustment functions.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the subject device and predicate device are similar. They are both intended to use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system.
The indications for use of the subject device and the predicate device is only different in expression. This difference does not raise different questions of safety and effectiveness of the subject device.
Technological Comparison
21 CFR 807.92(a)(6)
The subject Single-use Video Cholangioscope and the predicate SpyScope DS II Access and Delivery Catheter (K183636) share the similar technological characteristics, including CMOS image sensors for visualization, two LED illumination light modules for lighting, one working channel for inserting accessory and suction, two irrigation channels for water supply and four directions bending function controlled by the wheel on the handle.
The technological characteristics difference between the subject and predicate endoscope is that the lighting method (internal LED for subject device, and external LED for predicate device), dimensions (e.g. outer diameter of insertion section, working length) and optical specifications (depth of field, bending angle) are slightly difference. However, these differences do not raise different question of safety and effectiveness of the subject device.
The main configuration, dimension and weight,video signal output, white balance, image processor function and LCD display of the subject Full HD Visualization Endoscopic Image Processor are different from or similar as the predicate SpyGlass DS Digital Controller (K183636). These differences will not raise new question on safety and effectiveness of the subject device based on the comparison test report of the subject device and predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The following performance data were provided in support of the substantial equivalence determination. The test results demonstrated that the subject device complies with the standard requirements.
Electrical Safety and Electromagnetic Compatibility Summary:
The electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2), IEC 60601-2-18:2009 (Edition 3.0) and IEC 60601-1-2:2014+A1:2020 (Edition 4.1).
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K251338 Page 3 of 3
Photobiological safety:
The photobiological safety testing was tested in accordance with IEC 62471:2006.
Optical performance:
The subject device was designed to comply with applicable parts of ISO 8600-1: 2015, ISO 8600-3:2019, ISO 8600-4: 2014. Optical performance comparison testing was conducted on the subject device and predicate device. The optical performance test includes Intensity Uniformity, Depth of field, Resolution, Color Reproduction, Geometric Distortion, Noise and Dynamic Range, Image Frame Frequency and System Delay test.
Mechanical Performance Testing:
The mechanical performance testing was conducted to demonstrate the subject cholangioscope can function as intended. The mechanical performance testing includes the leakage testing, tensile strength testing and bending angle testing.
Shelf Life and Service Life (Use Life):
Three years shelf life was validated by accelerated aging per ASTM F1980-21 for Single-use Video Cholangioscope, and ten years use-life verification was conducted for Full HD Visualization Endoscopic Image Processor.
Package Validation:
Simulated distribution was conducted per ASTM D4169-22 after accelerated aging.
Package integrity testing of the Single-use Video Cholangioscope was conducted before the accelerated aging and after the simulated distribution according to ASTM F1886/F1886M-16, ASTM F88/F88M-21, ASTM F1929-15.
ERCP Model Simulation Testing
An in vitro ERCP model simulation test was conducted to demonstrate the subject cholangioscope may perform as intended when used with the duodenoscope during Endoscopic Retrograde Cholangiopancreatography Procedures (ERCP).
The clinical data is not applicable.
The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.