Home / 510(k) Clearances / K181151

510(k) K181151

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System by Ethicon, Inc. — Product Code PWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2018
Date Received
May 1, 2018
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

Other clearances by Ethicon, Inc.

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)
  • K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
  • K201996 — Monocryl Plus Antibacterial Suture (December 21, 2020)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K201143 — VICRYL Mesh (August 6, 2020)
  • K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (March 25, 2020)

Other clearances for product code PWJ

  • K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GY (July 6, 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)