FDA 510(k)

Flexible Video-Choledochoscope System

K-번호: K222261 · 2023-04-20

신청자Shanghai SeeGen Photoelectric Technology Co., Ltd.

결정일2023-04-20

제품 코드FBN

자문 위원회GU

결정Substantially Equivalent

기기 요약

Flexible Video-Choledochoscope 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 2023-04-20 under 510(k) number K222261. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flexible Video-Choledochoscope System?

Flexible Video-Choledochoscope System is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222261.

When did Flexible Video-Choledochoscope System receive FDA 510(k) clearance?

Flexible Video-Choledochoscope System received FDA 510(k) clearance on 2023-04-20, under 510(k) number K222261.

Who is the listed applicant for Flexible Video-Choledochoscope 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-Choledochoscope System?

The FDA product code for Flexible Video-Choledochoscope System is FBN.

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 K211686Flexible Video-Choledo-Cysto-Ureteroscope System

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