FDA 510(k)

플렉시-시얼 프로텍트 플러스 대변 관리 시스템 (ENFit 커넥터 포함)

K-번호: K190114 · 2019-04-30

결정일2019-04-30

제품 코드KNT

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190114. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Convatec Limited. The 510(k) number is K190114.

When did Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) receive FDA 510(k) clearance?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190114.

Who is the listed applicant for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

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 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

The FDA product code for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is KNT.

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