FDA 510(k)

GentleCath Glide 간헐적 케빈관

K-번호: K161344 · 2016-09-20

결정일2016-09-20

제품 코드KOD

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

GentleCath Glide Intermittent 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 2016-09-20 under 510(k) number K161344. 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 Glide Intermittent Catheter?

GentleCath Glide Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Convatec Limited. The 510(k) number is K161344.

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

GentleCath Glide Intermittent Catheter received FDA 510(k) clearance on 2016-09-20, under 510(k) number K161344.

Who is the listed applicant for GentleCath Glide Intermittent 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 Catheter?

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

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