FDA 510(k)

치유Ultra 남성용, 치유Ultra 여성용, 치유Ultra 플러스

K-번호: K221593 · 2022-11-17

결정일2022-11-17

제품 코드EZD

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K221593. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Convatec, Inc.. The 510(k) number is K221593.

When did Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus receive FDA 510(k) clearance?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus received FDA 510(k) clearance on 2022-11-17, under 510(k) number K221593.

Who is the listed applicant for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

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

What is the FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

The FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is EZD.

Convatec, Inc.를 신청인으로 등재한 기타 기록

K230400치료 캐터터 클로즈드 시스템; 치료 디엑사 클로즈드 시스템

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