(237 days)
PENTAX Medical Video Upper GI Scopes (EG Family):
This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
PENTAX Medical Video Colonoscopes (EC Family):
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
PENTAX Medical Video Upper GI Scopes (EG Family)
These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
PENTAX Medical Video Colonoscopes (EC Family)
These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 16, 2025
PENTAX of America, Inc
Gurvinder Singh Nanda
Senior Director, Regulatory and Quality
3 Paragon Dr
Montvale, New Jersey 07645
Re: K251256
Trade/Device Name: PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDS, FDF
Dated: November 14, 2025
Received: November 14, 2025
Dear Gurvinder Singh Nanda:
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.
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K251256 - Gurvinder Singh Nanda
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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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K251256 - Gurvinder Singh Nanda
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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,
SIVAKAMI VENKATACHALAM -S
for
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
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Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family);
PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
Please provide your Indications for Use below.
PENTAX Medical Video Upper GI Scopes (EG Family):
This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
PENTAX Medical Video Colonoscopes (EC Family):
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
PENTAX Medical Video Upper GI Scopes (EG Family) Page 11 of 71
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PENTAX Medical Video Upper GI Scopes (EG Family) PENTAX Medical Video Colonoscopes (EC Family) Traditional 510(k) Submission
Page 1 of 7
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 221 CFR 807.92. All data included in this document is accurate and complete to the best of PENTAX Medical's knowledge.
1. SUBMITTER
Applicant: PENTAX Medical
HOYA Corporation PENTAX Division
3 Paragon Drive
Montvale, New Jersey 07645-1782
Contact: Gurvinder Singh Nanda, PhD
Sr. Director, Regulatory and Quality
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Telephone: 650-722-4189
Email: gurvinder.nanda@pentaxmedical.com
Date Prepared: 04/22/2025
2. SUBJECT DEVICE and PREDICATE DEVICE
PENTAX Medical is seeking clearance of PENTAX Medical Video Upper GI Scopes (EG Family) and PENTAX Medical Video Colonoscopes (EC Family). Table 1 provides the regulatory information for the subject devices.
K251256 pg 1/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
Page 2 of 7
Table 1. Regulatory Information for the Subject Devices
| Device Name | PENTAX Medical Video Upper GI Scopes (EG Family) | PENTAX Medical Video Colonoscopes (EC Family) |
|---|---|---|
| Common Name | Gastroscope And Accessories, Flexible/Rigid | Colonoscope And Accessories, Flexible/Rigid |
| Classification Name | Endoscope and accessories | |
| Regulation No. | 876.1500 | |
| Device Class | II | |
| Product Code | FDS | FDF |
| Classification Panel | Gastroenterology / Urology |
Previously cleared PENTAX Medical Video Scopes have been selected as predicate devices, as shown in Table 2 below. The specific model names of the subject devices are listed in Table 3.
Table 2. Subject Devices and Predicate Devices
| Subject Device | Predicate Device |
|---|---|
| PENTAX Medical Video Upper GI Scopes (EG Family) | PENTAX Medical Video Upper GI Scopes (EG Family) (K131902) |
| PENTAX Medical Video Colonoscopes (EC Family) | PENTAX Medical Video Colonoscopes (EC Family) (K131855) |
Table 3. Specific Model Names of Subject Devices
| PENTAX Medical Video Upper GI Scopes (EG Family) | EG-2490K, EG27-i10, EG-2990i, EG29-i10, EG-3890TK |
|---|---|
| PENTAX Medical Video Colonoscopes (EC Family) | EC-2990Li, EC-3890Li, EC-3890TLK, EC34-i10L, EC38-i10L |
K251256 pg 2/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
Page 3 of 7
3. DEVICE DESCRIPTION
PENTAX Medical Video Upper GI Scopes (EG Family)
These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
PENTAX Medical Video Colonoscopes (EC Family)
These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
4. INTENDED USE AND INDICATIONS FOR USE
Intended use and Indications for use for PENTAX Medical Video Upper GI Scopes (EG Family)
This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
Intended use and Indications for use for PENTAX Medical Video Colonoscopes (EC Family)
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
K251256 pg 3/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
Page 4 of 7
5. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE/REFERENCE DEVICES
The subject devices are identical to the predicate devices. The subject devices have the same fundamental technology and operating principles of the predicate devices, including the same intended use and designs, such as Insertion Portion, Control Body and fiberoptic illumination. There are no differences in specifications, including, but not limited to, the depth of field, distal end width, insertion tube width, instrument channel width, and total length.
The changes between the subject and predicate devices are limited to labeling updates, change in Reprocessing procedure, mechanical modifications for compliance with IEC 60601-1-2, and patient-contact material changes. The changes made to the subject device have been evaluated through successful performance testing, with no safety or effectiveness concerns identified. These differences do not impact on the overall performance, functionality, or intended use of the device.
K251256 pg 4/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
Page 5 of 7
6. NON-CLINICAL PERFORMANCE DATA
The subject devices have been successfully tested for their functions, performance, and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.
i. Reprocessing Validation
As result of the assessment, simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of the subject devices were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Acceptance criteria were established in accordance with AAMI ST98:2022 for amount of residual soil accumulation and extraction efficiency. All acceptance criteria were satisfied.
ii. Sterilization and Shelf Life
PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the subject devices. The device is not provided sterile; therefore, shelf-life is not applicable.
iii. Biocompatibility
The biocompatibility characteristics of the subject devices are identical to those of the predicate device. There are no changes in the type of tissue contact, or the duration of contact compared to the predicate device. The biological risks associated with the subject devices have been determined to be acceptable.
iv. Software and Cybersecurity
Additional software verification and validation are not required, as no software changes have been made. Cybersecurity assessments are also not required because the subject devices have no network connection.
v. Electrical Safety and EMC
The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by the following standards:
IEC 60601‐1‐2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601‐2‐18:2009.
K251256 pg 5/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
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vi. System Performance
Performance bench testing related to mechanical, transport/environment, chemical durability, and compatibility with disinfectants and sterilizer/AER systems were conducted and met the acceptance criteria. The system performances of the subject devices demonstrated equivalence to the predicate devices.
vii. Optical Performance
Additional optical performance tests are not required, as no modifications or updates which affect optical performance have been made to the subject devices.
viii. Human Factors study
PENTAX Medical conducted a gap analysis between the pre-modification and post-modification versions of the Reprocessing Instruction for Use, in accordance with FDA's 2016 HFE guidance "Applying Human Factors and Usability Engineering to Medical Devices". As the result of the analysis, PENTAX Medical determined that no new critical tasks were introduced by the changes, and therefore, Human Factors study is not required.
K251256 pg 6/7
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PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX Medical Video Colonoscopes (EC Family)
Traditional 510(k) Submission
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Substantial Equivalence Discussion:
After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labeling, and sterilization method, PENTAX Medical concludes that the subject devices are as safe and effective as the predicate devices. There are no differences in the indications for use or intended use between the subject and predicate devices; therefore, they are considered substantially equivalent.
7. CONCLUSION
The subject devices do not pose any questions regarding safety or effectiveness. They are deemed to be substantially equivalent to the identified predicate devices: PENTAX Medical Video Upper GI Scopes (EG Family) (K131902) and PENTAX Medical Video Colonoscopes (EC Family) (K131855).
K251256 pg 7/7
§ 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.