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Biomerix Ventral Hernia Repair Mesh, Model SM3-TAB

by Biomerix Corporation

510(k) K093123

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK093123 Date13 May 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
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.

Biomerix Ventral Hernia Repair Mesh, Model SM3-TAB is a sterile, composite surgical mesh for hernia repair and soft tissue reconstruction. It consists of three layers: a Biomerix Biomaterial sheet, knitted polypropylene monofilament fibers, and a resorbable lactide-caprolactone film.

The device is supplied sterile and is intended for single-use. It is classified as a Class II medical device under regulation number 878.3300 with product code FTL, and received FDA 510(k) clearance (K093123) on May 13, 2010, following a traditional review process. The device is indicated for use in general and plastic surgery procedures.

Other devices from Biomerix Corporation

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 Biomerix Ventral Hernia Repair Mesh Model SM3-TAB used for?

    The Biomerix Ventral Hernia Repair Mesh Model SM3-TAB is indicated for use in general and plastic surgery procedures, specifically for hernia repair and soft tissue reconstruction, as stated in the device description.

  • Is the Biomerix Ventral Hernia Repair Mesh Model SM3-TAB sterile and single-use?

    Yes, the device is supplied sterile and is intended for single-use, as explicitly stated in the description, ensuring it is used only once to maintain sterility and prevent cross-contamination.

  • What materials make up the Biomerix Ventral Hernia Repair Mesh Model SM3-TAB?

    The device consists of three layers: a Biomerix Biomaterial sheet, knitted polypropylene monofilament fibers, and a resorbable lactide-caprolactone film, forming a composite structure designed for surgical integration and tissue support.