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FDA 510(k)

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

K-Number: K181151 · 2018-08-10

ApplicantETHICON, Inc.
Decision Date2018-08-10
Product CodePWJ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2018-08-10 under approval number K181151. 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 Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by ETHICON, Inc.. The 510(k) number is K181151.

When was GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System approved by the FDA?

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System received FDA 510(k) clearance on 2018-08-10, under approval number K181151.

What company makes GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is manufactured by ETHICON, Inc..

What is the FDA product code for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

The FDA product code for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is PWJ.

Related Clinical Trials

NCT04829994 Post-Market Clinical Follow-Up onTVT EXACT® Continence System ACTIVE_NOT_RECRUITING NCT04829357 Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System RECRUITING NCT07146165 Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM) RECRUITING

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Related Devices (Code: PWJ)

K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery DeviceBoston Scientific Corporation K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System TrocarETHICON, Inc. K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter GuideETHICON, Inc. K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, LeftCaldera Medical, Inc.

Official Source

View on FDA Database →

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

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