FDA 510(k)

LiftUp (참조 번호: 200.56.01), LiftUp 키트 (참조 번호: 200.56.02)

K-번호: K221385 · 2022-08-11

결정일2022-08-11

제품 코드PLL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K221385. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K221385.

When did LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) receive FDA 510(k) clearance?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) received FDA 510(k) clearance on 2022-08-11, under 510(k) number K221385.

Who is the listed applicant for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

The FDA 510(k) record lists Ovesco Endoscopy AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

The FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is PLL.

Ovesco Endoscopy AG를 신청인으로 등재한 기타 기록

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)K251562OTSCneo 시스템 세트 (100.03n-14n, 100.27n-31n)K242586ArgoCap (200.52)K241858BARS Set (100.60)K200684gastroduodenal FTRD Set K183309stentfix OTSC System Set

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