FDA 510(k)

플렉시블 비디오 조도-췌도-胱도-우레테로스코프 시스템 (PL-2100)

K-번호: K241532 · 2024-10-22

신청자Shanghai SeeGen Photoelectric Technology Co., Ltd.

결정일2024-10-22

제품 코드FET

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) 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 2024-10-22 under 510(k) number K241532. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K241532.

When did Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) received FDA 510(k) clearance on 2024-10-22, under 510(k) number K241532.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

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 (PL-2100)?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is FET.

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

K252457용기부수 끝 라벨 히트캡 K243535플렉시블 비디오 콜레도스코프 (CHV-110J-U); 플렉시블 비디오 콜레도스코프 (CHV-US120J-U)K222499용기 Endoscope 밸브 키트 K222261플렉시블 비디오 콜레도스코프 시스템 K211686플렉시블 비디오 조루도-膀胱-우레테로스코프 시스템

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