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510(k) K173019

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar by Ethicon, Inc. — Product Code PWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
September 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class
Class II
Regulation Number
884.4910
Review Panel
GU
Submission Type

Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence

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Other clearances for product code PWJ

  • K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (August 10, 2018)
  • K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, G (June 28, 2018)
  • K172614 — Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transob (May 4, 2018)
  • K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery D (December 20, 2017)