FDA 510(k)

재제작된 엔도와이스트 코브라 그래스퍼 (420190)

K-번호: K250417 · 2025-08-20

결정일2025-08-20

제품 코드QSM

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Remanufactured EndoWrist Cobra Grasper (420190) is the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K250417. The device is classified under product code QSM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Remanufactured EndoWrist Cobra Grasper (420190)?

Remanufactured EndoWrist Cobra Grasper (420190) is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Rebotix. The 510(k) number is K250417.

When did Remanufactured EndoWrist Cobra Grasper (420190) receive FDA 510(k) clearance?

Remanufactured EndoWrist Cobra Grasper (420190) received FDA 510(k) clearance on 2025-08-20, under 510(k) number K250417.

Who is the listed applicant for Remanufactured EndoWrist Cobra Grasper (420190)?

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

What is the FDA product code for Remanufactured EndoWrist Cobra Grasper (420190)?

The FDA product code for Remanufactured EndoWrist Cobra Grasper (420190) is QSM.

Rebotix를 신청인으로 등재한 기타 기록

K250399재제작된 엔도와스트 카디에어 포스프스 (420049)K250387재제작된 엔도와스트 장단형 forceps (420048)K250539재제작된 엔도와스트 테나쿨럼 forceps (420207)K241872재제작된 EndoWrist ProGrasp Forceps (420093)

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