FDA 510(k)

单次使用活检阀（MAJ-1555）

K号: K251997 · 2025-09-25

决定日期2025-09-25

产品代码OCX

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决定实质等同

器械摘要

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.

常见问题

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)?

FDA 510(k)记录显示，Olympus Medical Systems Corporation为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Olympus Medical Systems Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260824胃肠内窥镜奥林巴斯 GIF-2T1500 K260856一次性远端附件 D-201-13404 K260401EVIS EUS 超声支气管纤维内窥镜 OLYMPUS BF-UCP190F（BF-UCP190F）K261183EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）K261260HD 摄像头 OLYMPUS CH-S200-08-LB K252050一次性活检镊 FB-211D, FB-221D, FB-231D, FB-241D

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官方来源

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