Re: K243535 - 510(k) Premarket Notification Substantially Equivalent Determination Letter

Oct 6, 2026

Uploaded by Patrick

March 7, 2025 letter from the FDA to Die Li of Shanghai SeeGen Photoelectric Technology Co., Ltd. regarding 510(k) premarket notification K243535 for Flexible Video-Choledochoscope (CHV-110J-U; CHV-US120J-U). FDA determines the device is substantially equivalent to legally marketed predicate devices for stated indications for use, allowing marketing under general controls. The letter highlights applicable requirements, including registration and listing, labeling truthfulness, quality system rules, and UDI/GUDID obligations.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Regulatory decision and scope

Substantial equivalence determination

General controls and applicable requirements

Quality System (QS) requirements

UDI Rule and GUDID submissions

Misbranding and adverse event reporting

March 7, 2025 Shanghai SeeGen Photoelectric Technology Co., Ltd. Die Li RA specialist 3 Floor, Building No.1, 4299 JinDu Road Minhang District Shanghai, China 201108 China Re: K243535 Trade/Device Name: Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video Choledochoscope (CHV-US120J-U) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN Dated: February 7, 2025 Received: February 7, 2025 Dear Die Li: 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies)[ identifies](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. Weremind 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. 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](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](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 P

FAQs

What does the FDA determine for K243535 under the 510(k) process?

The FDA determines the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure, subject to general controls.

Can the manufacturer market the device after receiving this letter?

Yes. The letter states that you may market the device subject to the Act’s general controls provisions.

Which regulatory obligations does the letter emphasize beyond the equivalence determination?

The letter emphasizes compliance with registration and listing, labeling requirements, medical device reporting and postmarketing safety reporting where applicable, Quality System requirements (21 CFR Part 820), and the UDI Rule and related GUDID submissions.

Oct 6, 2026

Uploaded by Patrick