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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 a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-22 under approval 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. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222499.

When was Disposable Endoscope Valves Kit approved by the FDA?

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

What company makes Disposable Endoscope Valves Kit?

Disposable Endoscope Valves Kit is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Disposable Endoscope Valves Kit?

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

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

K211686Flexible Video-Choledo-Cysto-Ureteroscope System K222261Flexible Video-Choledochoscope System K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) K252457Disposable Distal End Tape Hood

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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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