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Proceed Surgical Mesh

by Ethicon Inc.

510(k) K060713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK060713 Date25 May 2006ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-1329-2014 FDA Class II initiated 19 Feb 2014 on shared 510(k) K060713

    The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

    • Ongoing Z-0903-2011 FDA Unclassified (pre-2012) initiated 18 Oct 2010

    There is a potential for delamination in one lot of Proceed surgical mesh.

    • Terminated Z-0533-2021 FDA Class II initiated 23 Oct 2020

    The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

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  • Withdrawn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
FTL
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Proceed Surgical Mesh is a polymeric surgical mesh device. It is classified as a mesh, surgical, polymeric device under FDA regulations.

The device received FDA 510(k) clearance (K060713) on May 25, 2006, and is substantially equivalent to a predicate device. It is manufactured by Ethicon Inc. and is intended for use in general and plastic surgery applications.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Proceed Surgical Mesh used for?

    The Proceed Surgical Mesh is intended for use in general and plastic surgery applications as a polymeric surgical mesh device, providing tissue support and reinforcement during surgical procedures.

  • How is the Proceed Surgical Mesh supplied and is it sterile?

    The device is supplied as a sterile polymeric surgical mesh, though specific packaging details are not provided in the authorization data; sterility is implied by its classification as a surgical implant requiring aseptic handling.

  • Is the Proceed Surgical Mesh reusable or single-use?

    The Proceed Surgical Mesh is a single-use implantable device, as it is designed for permanent implantation during surgery and cannot be resterilized or reused after removal from its sterile barrier.

  • What regulatory pathway was used for the Proceed Surgical Mesh?

    The Proceed Surgical Mesh received FDA 510(k) clearance under submission K060713 on May 25, 2006, demonstrating substantial equivalence to a predicate device in the same class.

  • What are the key identifiers for the Proceed Surgical Mesh in the FDA database?

    The device is identified by the name PROCEED SURGICAL MESH, K-number K060713, product code FTL, and regulation number 878.3300, manufactured by Ethicon Inc. in Somerville, NJ.