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FluoroTex Surgical Mesh

by Bridger Biomed, Inc. 510(k)

Active United States

510(k) K984197

Overview

FluoroTex Surgical Mesh is a porous expanded polytetrafluoroethylene (ePTFE) sheet reinforced with fluorinated ethylene propylene (FEP). It is intended to be used for the repair of soft tissue and the reconstruction of hernias. The device functions as a mechanical implant to provide structural support in surgical procedures.

The device is supplied as a sterile, single-use implant. It is available in various sizes as specified by the manufacturer. FluoroTex Surgical Mesh is classified as a Class 2 device with product code FTL and has received FDA 510(k) clearance under regulation number 878.3300.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984197 Date7 Jan 1999ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Other devices from Bridger Biomed, Inc.

Questions

  • What is FluoroTex Surgical Mesh used for?

    FluoroTex Surgical Mesh is intended for the repair of soft tissue and reconstruction of hernias. It functions as a mechanical implant to provide structural support during surgical procedures.

  • Is FluoroTex Surgical Mesh reusable or single-use?

    FluoroTex Surgical Mesh is supplied as a sterile, single-use implant. It should not be reused or resterilized for patient safety and regulatory compliance.

  • What sizes and models of FluoroTex Surgical Mesh are available?

    FluoroTex Surgical Mesh is available in various sizes as specified by the manufacturer. The specific dimensions and models should be selected based on the surgical requirements and manufacturer's guidelines.

  • What is the regulatory classification of FluoroTex Surgical Mesh?

    FluoroTex Surgical Mesh is classified as a Class 2 device with product code FTL. It has received FDA 510(k) clearance under regulation number 878.3300, indicating it is substantially equivalent to predicate devices.