FDA 510(k)

GentleCath Glide 간헐적 배뇨 케테터

K-번호: K181206 · 2018-08-16

결정일2018-08-16

제품 코드GBM

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

GentleCath Glide 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 2018-08-16 under 510(k) number K181206. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GentleCath Glide Intermittent Urinary Catheter?

GentleCath Glide Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Convatec Limited. The 510(k) number is K181206.

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

GentleCath Glide Intermittent Urinary Catheter received FDA 510(k) clearance on 2018-08-16, under 510(k) number K181206.

Who is the listed applicant for GentleCath Glide 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 Glide Intermittent Urinary Catheter?

The FDA product code for GentleCath Glide Intermittent Urinary Catheter is GBM.

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