FDA 510(k)

GentleCath 간헐적 배뇨 케락

K-번호: K172924 · 2017-11-21

결정일2017-11-21

제품 코드KOD

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

GentleCath Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172924. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GentleCath Intermittent Urinary Catheter?

GentleCath Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Convatec Limited. The 510(k) number is K172924.

When did GentleCath Intermittent Urinary Catheter receive FDA 510(k) clearance?

GentleCath Intermittent Urinary Catheter received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172924.

Who is the listed applicant for GentleCath Intermittent Urinary Catheter?

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

What is the FDA product code for GentleCath Intermittent Urinary Catheter?

The FDA product code for GentleCath Intermittent Urinary Catheter is KOD.

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