FDA 510(k)

Single-Use Biopsy Valve (MAJ-1555)

K-번호: K251997 · 2025-09-25

결정일2025-09-25

제품 코드OCX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Single-Use Biopsy Valve (MAJ-1555) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251997. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Single-Use Biopsy Valve (MAJ-1555)?

Single-Use Biopsy Valve (MAJ-1555) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251997.

When did Single-Use Biopsy Valve (MAJ-1555) receive FDA 510(k) clearance?

Single-Use Biopsy Valve (MAJ-1555) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251997.

Who is the listed applicant for Single-Use Biopsy Valve (MAJ-1555)?

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

What is the FDA product code for Single-Use Biopsy Valve (MAJ-1555)?

The FDA product code for Single-Use Biopsy Valve (MAJ-1555) is OCX.

Olympus Medical Systems Corporation를 신청인으로 등재한 기타 기록

K260824장기경 영상검사기 오lympus GIF-2T1500 K260856용기부속 장치 D-201-13404 K260401EVIS EUS 울트라소운드 bronchofibervideoscope OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS 내장 초음파 비디오 스코프 (Olympus GF-UE190)K261260HD 카메라 헤드 올림푸스 CH-S200-08-LB K252050용기성 생검 forceps FB-211D, FB-221D, FB-231D, FB-241D

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