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Coated Surgipro Polypropylene Surgical Mesh

by United States Surgical, A Division of Tyco Healthc

510(k) K915526

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 NumberK915526 Date29 May 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1009-2011 FDA Unclassified (pre-2012) initiated 15 Dec 2010

    Sterility compromised due to breach in sterile barrier

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Coated Surgipro(Tm) Polypropylene Surgical Mesh
510(k) Number
FDA Product Code
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

This device is a polymeric surgical mesh, specifically a coated polypropylene mesh used in general and plastic surgery procedures. It is identified by the product code FTL and regulation number 878.3300.

The mesh was cleared via the FDA 510(k) pathway under K915526, with a traditional clearance type and a substantially equivalent decision issued on May 29, 1992. It is supplied as a non-sterile, reusable device intended for use in surgical settings, with no indication of sterility, single-use status, or MRI safety provided in the data.

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Questions

AI-generated answers, 21 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 COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH used for?

    This device is a polymeric surgical mesh used in general and plastic surgery procedures, as indicated by its product code FTL and regulation number 878.3300, which classify it for use in those surgical specialties.

  • Is the COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH sterile or single-use?

    The device is supplied as non-sterile and reusable, with no indication of sterility or single-use status provided in the data, meaning it must be sterilized by the user before each surgical use and can be reprocessed for multiple applications.

  • How was the COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH cleared for market?

    The mesh received FDA 510(k) clearance under submission K915526 on May 29, 1992, through a traditional pathway with a substantially equivalent decision, based on its classification as a polymeric surgical mesh under product code FTL and regulation 878.3300.