FDA 510(k)

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

Numéro K : K173019 · 2018-07-06

Date de décision2018-07-06

Code produitPWJ

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is ETHICON, Inc.. The 510(k) number is K173019.

When did GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar receive FDA 510(k) clearance?

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 510(k) number K173019.

Who is the listed applicant for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

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 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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Dispositifs connexes (Code : PWJ)

K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemETHICON, 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.K172565Dispositif de livraison Advantage/Advantage Fit, Dispositif de livraison Lynx, Dispositif de livraison Obtryx (Courbé & Halo), Dispositif de livraison Obtryx II (Courbé & Halo), Dispositif de livraison Solyx SISBoston Scientific Corporation

Source officielle

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