FDA 510(k)

Seal 单次使用活检阀

K号: K161167 · 2016-05-26

决定日期2016-05-26

产品代码OCX

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决定实质等同

器械摘要

Seal Single-Use Biopsy Valve is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K161167. 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 Seal Single-Use Biopsy Valve?

Seal Single-Use Biopsy Valve is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Endochoice, Inc.. The 510(k) number is K161167.

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

Seal Single-Use Biopsy Valve received FDA 510(k) clearance on 2016-05-26, under 510(k) number K161167.

Who is the listed applicant for Seal Single-Use Biopsy Valve?

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

What is the FDA product code for Seal Single-Use Biopsy Valve?

The FDA product code for Seal Single-Use Biopsy Valve is OCX.

列明Endochoice, Inc.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。

K160275带有FuseBox处理器的Fuse内窥镜系统 K161482EndoChoice 水瓶盖冲洗系统 K160403SmartStart 空气/水及吸引阀 K153588EndoChoice 水瓶盖系统 K151475EndoChoice Select 注射针

官方来源

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