(228 days)
The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.
The image processor provides power and processes the images for medical electronic endoscope.
The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).
The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.
The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.
This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.
Here's an analysis based on the provided document for the Medical Video Endoscope System:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA guidance "Use of International Standard ISO 10993-1" and ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated Pyrogens) | Evaluated in accordance with guidance; Complies |
| Sterilization & Shelf Life | ISO 11135:2014 (Sterilization Process Validation) | Validated |
| ISO 10993-7:2008 (EO/ECH Residual Test) | Performed (implies compliance) | |
| ASTM F1980-21 (Accelerated Aging for Shelf Life) | Shelf life determined based on optical testing and product performance after accelerated aging | |
| ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-23, ASTM F1929-23 (Package Validation) | Conducted (implies compliance) | |
| Electrical Safety & EMC | IEC 60601-1 (General Safety) | Complies |
| IEC 60601-2-18 (Endoscopic Equipment Specific Safety) | Complies | |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies | |
| Software Verification & Validation | FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted, documentation provided (implies compliance) |
| Bench Performance Testing | ISO 8600 series (Optical Performance) | Complies |
| Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), Noise and dynamic range compared with the predicate device. | Bench tests performed (implies meeting performance comparable to predicate) | |
| Mechanical testing (use-life of bending section and control knob, connection strength, peak tensile force, corrosion resistance etc.) | Bench tests performed (implies meeting performance) |
2. Sample Sizes Used for Test Set and Data Provenance
This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
Not applicable. This device is a physical endoscope system, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this medical device's performance is established by:
- International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
- Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
- Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
Summary of Device and Performance:
The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.
The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:
- Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
- Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
- Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
- Software Verification and Validation: Conducted and documented as per FDA guidance.
- Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).
The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.
FDA 510(k) Clearance Letter - Medical Video Endoscope System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov
August 26, 2025
Seplou (ZHUHAI) Co., Ltd.
℅ Jie Yang
Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong
CHINA
Re: K250049
Trade/Device Name: Medical Video Endoscope [Standard Deflection] (URS3005);
Medical Video Endoscope [Reverse Deflection] (URS3005E);
Medical Video Endoscope [Standard Deflection] (URS3006);
Medical Video Endoscope [Reverse Deflection] (URS3006E);
Medical Video Endoscope [Standard Deflection] (URS3016);
Medical Video Endoscope [Reverse Deflection] (URS3016E);
Image processor (DIS8000)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FGB
Dated: July 21, 2025
Received: July 21, 2025
Dear Jie Yang:
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.
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K250049 - Jie Yang Page 2
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.
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-
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K250049 - Jie Yang Page 3
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-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,
MARK J. ANTONINO -S
Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology 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.
Submission Number (if known)
K250049
Device Name
Medical Video Endoscope [Standard Deflection] (URS3005);
Medical Video Endoscope [Reverse Deflection] (URS3005E);
Medical Video Endoscope [Standard Deflection] (URS3006);
Medical Video Endoscope [Reverse Deflection] (URS3006E);
Medical Video Endoscope [Standard Deflection] (URS3016);
Medical Video Endoscope [Reverse Deflection] (URS3016E);
Image processor (DIS8000)
Indications for Use (Describe)
The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.
The image processor provides power and processes the images for medical electronic endoscope.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92 on August 18, 2025
1. Submission sponsor
Name: SEPLOU (ZHUHAI) CO., LTD.
Address: 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, 519085, Zhuhai, Guangdong, P.R. China
Contact person: Zeng QingFu
Title: Regulatory Affairs Manager
E-mail: Vince@seplou.com
Tel: 86-0756-8858005
2. Submission correspondent
Name: Chonconn Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: yangjie@chonconn.com
Tel: +86-755 33941160
3. Subject Device Information
| Trade/Device Name | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) |
|---|---|
| Common Name | Endoscope and accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 876.1500 / Ureteroscope And Accessories, Flexible/Rigid / FGB |
| Submission type | Traditional 510(K) |
4. Predicate Device
510(k) number: K172098
Product name: Medical Video Endoscope System
Product code: FGB
K250049
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5. Device Description
The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).
The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.
The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.
6. Indications for use
The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.
The image processor provides power and processes the images for medical electronic endoscope.
7. Comparison to the Predicate Device
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Medical Video Endoscope: [Standard Deflection]: URS3005, URS3006, URS3016 [Reverse Deflection]: URS3005E, URS3006E, URS3016E Image Processor: DIS8000 | Medical Video Endoscope System | ||
| K number | K250049 | K172098 | / |
| Product Code | FGB | FGB | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Device trade name | Medical Video Endoscope Image Processor | Medical Video Endoscope System | / |
| Indication for use | The Medical Video Endoscope is designed to be used with | This instrument has been | Same |
K250049
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| endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery. The image processor provides power and processes the images for medical electronic endoscope. | designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. | ||
|---|---|---|---|
| Anatomical Site | Urinary tract and interior of the kidney | Urinary tract and interior of the kidney | Same |
| Target population | Adults | Adults | Same |
| Where used | Hospital | Hospital | Same |
| Medical Video Endoscope | |||
| Scope type | Flexible | Flexible | Same |
| Single use/ Reuse | Single use | Single use | Same |
| Sterile | Yes | Yes | Same |
| Sterilization Method | EO sterilization | EO sterilization | Same |
| SAL | 10⁻⁶ | 10⁻⁶ | Same |
| Field of view | 120° | 120° | Same |
| Direction of view | 0° | 0° | Same |
| Sensor type | CMOS | CMOS | Same |
| Illumination source | LED | LED | Same |
| Max. outer diameter of insertion section | 3.0mm 2.5mm 2.2mm | 3.2mm | Similar |
| Up/down deflection | Up:275° Down: 275° | Up:270° Down: 270° | Similar |
| Work length | 650mm | 650mm | Same |
| Minimum instrument channel width | 1.2mm | 1.0mm | Similar |
K250049
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| Product Performance | Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4 | Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4 | Same |
|---|---|---|---|
| Biocompatibility | Cytotoxicity: ISO 10993-5 Sensitization: ISO 10993-10 Irritation: ISO 10993-10 Acute Systemic Toxicity: ISO 10993-11 Material-mediated Pyrogens: ISO 10993-11 | Cytotoxicity: ISO 10993-5 Sensitization: ISO 10993-10 Irritation: ISO 10993-10 | Different |
| Image system | Image Processor DIS8000 | UTV100 as the image system | Same |
8. Non-clinical Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Medical Video Endoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Sterilization and shelf life testing
The Medical Video Endoscope is provided sterile and its shelf-life is 3 years.
Sterilization Process has been validated accordance with ISO 11135:2014.
EO/ECH residual test was performed according to ISO 10993-7:2008.
The shelf life is determined based on optical testing and product performance testing after accelerated aging test according to ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F1886/F1886M-16, ASTM F88/F88M-23, ASTM F1929-23.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Video Endoscope system. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
K250049
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Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Bench performance testing
The following bench tests were performed:
- Optical performance testing according to ISO 8600 series.
- Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), Noise and dynamic range compared with the predicate device.
- Mechanical testing including use-life of bending section and control knob, connection strength, peak tensile force and corrosion resistance etc.
9. Clinical study
Not applicable.
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed Medical Video Endoscope system is substantially equivalent to the predicate device.
K250049
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§ 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.