SpeedCath Compact Male — FDA 510(k) K210250

기기 요약

SpeedCath Compact Male is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K210250. 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 SpeedCath Compact Male?

SpeedCath Compact Male is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Coloplast. The 510(k) number is K210250.

When did SpeedCath Compact Male receive FDA 510(k) clearance?

SpeedCath Compact Male received FDA 510(k) clearance on 2022-04-26, under 510(k) number K210250.

Who is the listed applicant for SpeedCath Compact Male?

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

What is the FDA product code for SpeedCath Compact Male?

The FDA product code for SpeedCath Compact Male is EZD.

Coloplast를 신청인으로 등재한 기타 기록

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

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관련 기기 (코드: EZD)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

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