FDA 510(k)

스노우든-펜서 에르고닉 분리 가능한 인라인 및 핸드그립 라파로스코픽 도구

K-번호: K151036 · 2016-02-01

결정일2016-02-01

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K151036. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K151036.

When did Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments receive FDA 510(k) clearance?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments received FDA 510(k) clearance on 2016-02-01, under 510(k) number K151036.

Who is the listed applicant for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is GCJ.

Carefusion 2200, Inc.를 신청인으로 등재한 기타 기록

K210324V. Mueller Cosgrove 플렉스 클램프, 모델 번호-CV1033, CV1061, CV1133, CV1161, CV1186 K163615스노우든-펜서 마이크로랩 3mm 라파로스코픽 도구 K162432다이어링크 X2 심전도 케이블 및 리드 와이어 시스템 K160764AirLife Autofill Humidification Chamber K153554제니스 저온 재사용 고정형 컨테이너 시스템

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