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FDA 510(k)

Disposable Distal End Tape Hood

K-Number: K252457 · 2026-01-30

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2026-01-30
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Distal End Tape Hood is a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under approval number K252457. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Distal End Tape Hood?

Disposable Distal End Tape Hood is a medical device that received FDA 510(k) clearance on 2026-01-30. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K252457.

When was Disposable Distal End Tape Hood approved by the FDA?

Disposable Distal End Tape Hood received FDA 510(k) clearance on 2026-01-30, under approval number K252457.

What company makes Disposable Distal End Tape Hood?

Disposable Distal End Tape Hood is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Disposable Distal End Tape Hood?

The FDA product code for Disposable Distal End Tape Hood is FDF.

Other Devices by Shanghai SeeGen Photoelectric Technology Co., Ltd.

K211686Flexible Video-Choledo-Cysto-Ureteroscope System K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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