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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) 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. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K252457.

When did Disposable Distal End Tape Hood receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Distal End Tape Hood?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Shanghai SeeGen Photoelectric Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)K222499Disposable Endoscope Valves KitK222261Flexible Video-Choledochoscope SystemK211686Flexible Video-Choledo-Cysto-Ureteroscope System

Related Devices (Code: FDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems CorporationK242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, 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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