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FDA 510(k)

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

K-Number: K173019 · 2018-07-06

ApplicantETHICON, Inc.
Decision Date2018-07-06
Product CodePWJ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2018-07-06 under approval number K173019. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by ETHICON, Inc.. The 510(k) number is K173019.

When was GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar approved by the FDA?

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar received FDA 510(k) clearance on 2018-07-06, under approval number K173019.

What company makes GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is manufactured by ETHICON, Inc..

What is the FDA product code for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

The FDA product code for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is PWJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.