FDA 510(k)

Flexible Video-Choledo-Cysto-Ureteroscope System

K-번호: K211686 · 2022-02-22

신청자Shanghai SeeGen Photoelectric Technology Co., Ltd.

결정일2022-02-22

제품 코드FGB

자문 위원회GU

결정Substantially Equivalent

기기 요약

Flexible Video-Choledo-Cysto-Ureteroscope System 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 2022-02-22 under 510(k) number K211686. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K211686.

When did Flexible Video-Choledo-Cysto-Ureteroscope System receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K211686.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System?

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 Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System is FGB.

Shanghai SeeGen Photoelectric Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K252457Disposable Distal End Tape Hood K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System

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