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Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair

by Gynecare, A Div. of Ethicon, Inc.

510(k) K013718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013718 Date8 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0795-2007 FDA Unclassified (pre-2012) initiated 20 Apr 2007 on shared 510(k) K013718

    The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OTO
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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