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FDA 510(k)

Disposable Endoscope Valves Kit

K-Number: K222499 · 2023-11-22

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2023-11-22
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Valves Kit 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 2023-11-22 under 510(k) number K222499. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscope Valves Kit?

Disposable Endoscope Valves Kit is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222499.

When did Disposable Endoscope Valves Kit receive FDA 510(k) clearance?

Disposable Endoscope Valves Kit received FDA 510(k) clearance on 2023-11-22, under 510(k) number K222499.

Who is the listed applicant for Disposable Endoscope Valves Kit?

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 Endoscope Valves Kit?

The FDA product code for Disposable Endoscope Valves Kit is ODC.

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.

K252457Disposable Distal End Tape HoodK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)K222261Flexible Video-Choledochoscope SystemK211686Flexible Video-Choledo-Cysto-Ureteroscope System

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

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

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