FDA 510(k)

GYNECARE TVT腹部导引器和连接器，GYNECARE TVT可重复使用导引器，GYNECARE TVT可重复使用刚性导管导引器

K号: K173162 · 2018-06-28

决定日期2018-06-28

产品代码PWJ

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决定实质等同

器械摘要

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K173162. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide?

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is ETHICON, Inc.. The 510(k) number is K173162.

When did GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide receive FDA 510(k) clearance?

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide received FDA 510(k) clearance on 2018-06-28, under 510(k) number K173162.

Who is the listed applicant for GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide?

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

What is the FDA product code for GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide?

The FDA product code for GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide is PWJ.