FDA 510(k)

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

K-Number: K181151 · 2018-08-10

Decision Date2018-08-10

Product CodePWJ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) 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. The listed applicant is ETHICON, Inc.. The 510(k) number is K181151.

When did GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System receive FDA 510(k) clearance?

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

Who is the listed applicant for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

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 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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04829357Post Market Clinical Follow-up Study on TVT ABBREVO® Continence SystemRECRUITING NCT04829994Post-Market Clinical Follow-Up onTVT EXACT® Continence SystemACTIVE_NOT_RECRUITING NCT04829175Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryRECRUITING NCT04829058GYNEMESH PS Mesh Post Marketing Clinical Follow-Up StudyRECRUITING NCT06664788A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open SurgeryRECRUITING

Other records listing ETHICON, Inc. as applicant

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Related Devices (Code: PWJ)

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.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

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.