FDA 510(k)

Creo 메디컬 전기수술 시스템 및 Speedboat RS2 수술 접근 부속품

K-번호: K171983 · 2017-08-17

결정일2017-08-17

제품 코드KNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171983. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K171983.

When did Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory receive FDA 510(k) clearance?

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171983.

Who is the listed applicant for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

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

What is the FDA product code for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

The FDA product code for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is KNS.

Creo Medical, Ltd.를 신청인으로 등재한 기타 기록

K242774스파이드블레이드 플렉스 장비 (PRD-RG1-001)K242983CROMA 전기수술 발생기 (PRD-EMR-050)K242061재사용 가능한 인터페이스 케이블 1.5 m (PRD-IFC-002)K230328스피드보트 플러시 SB1 장비 K223138AB1 전기 수술 도구, Creo 전기 수술 시스템 K221672크레오 전기수술 시스템 및 NP1 도구

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