WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252457

510(k) cleared

Disposable Distal End Tape Hood

Shanghai SeeGen Photoelectric Technology Co., Ltd. · Jan 30, 2026 · K252457

FDA cleared the Disposable Distal End Tape Hood from Shanghai SeeGen Photoelectric Technology Co., Ltd. on Jan 30, 2026 under K252457, a traditional 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 5, 2025. The decision came 178 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shanghai SeeGen Photoelectric Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252457?

K252457 is the FDA 510(k) for Disposable Distal End Tape Hood, submitted by Shanghai SeeGen Photoelectric Technology Co., Ltd.. FDA's decision date was Jan 30, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Disposable Distal End Tape Hood?

Shanghai SeeGen Photoelectric Technology Co., Ltd., based in Shanghai, is the applicant of record for K252457.

How long did the K252457 review take?

FDA received the submission on Aug 5, 2025 and issued its decision on Jan 30, 2026, 178 days later.

← All decisions in January 2026