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Timesh Also Known as Timesh-Tc, Models 6000001 & 6000004

by Gfe Medizintechnik GmbH

510(k) K031225

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 NumberK031225 Date29 Sep 2003ClearedStatusActive

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  • Withdrawn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, 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.

The device is a polymeric surgical mesh, classified as a mesh device for general and plastic surgery applications. It is identified by the models 6000001 and 6000004 and is also known as Timesh-Tc.

It received FDA 510(k) clearance under K031225 on September 29, 2003, as substantially equivalent to a predicate device. The device is supplied non-sterile and intended for reuse after appropriate cleaning and sterilization by the user, in accordance with labeling and regulatory requirements.

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 Timesh-Tc surgical mesh used for?

    The Timesh-Tc surgical mesh is a polymeric device intended for use in general and plastic surgery applications, providing tissue support and reinforcement during surgical procedures as indicated by its classification and intended use.

  • How is the Timesh-Tc surgical mesh supplied and prepared for use?

    The device is supplied non-sterile and must be cleaned and sterilized by the user prior to each use, following the manufacturer's labeling and applicable regulatory requirements for reuse.

  • Is the Timesh-Tc surgical mesh intended for single use or reuse?

    The Timesh-Tc surgical mesh is intended for reuse after appropriate cleaning and sterilization by the user, as explicitly stated in the device description and labeling instructions.

  • What models are included in the Timesh-Tc surgical mesh product line?

    The Timesh-Tc surgical mesh includes two specific models: 6000001 and 6000004, which are identified together under the device name and authorization.

  • What regulatory pathway was used for the Timesh-Tc surgical mesh clearance?

    The device received FDA 510(k) clearance under submission number K031225 on September 29, 2003, based on a determination of substantial equivalence to a predicate device.