Skip to content

iMESH Tacker

by Thd Lap

510(k) K153202

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 · Special NumberK153202 Date24 Mar 2016ClearedStatusActive

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  • Withdrawn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
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The iMESH Tacker is a medical device intended for the fixation of prosthetic material to soft tissue in minimally invasive and open general surgical procedures, such as hernia repair. It is classified as a Class II implantable device under FDA regulations.

The device is supplied as a sterile, single-use implant. It is not MRI safe and should be stored in a controlled environment. The iMESH Tacker has received FDA 510(k) clearance (K153202) as substantially equivalent to a predicate device.

Questions

AI-generated answers, 6 Oct 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 iMESH Tacker used for?

    The iMESH Tacker is a medical device designed to fix prosthetic material to soft tissue during minimally invasive or open general surgical procedures, such as hernia repair.

  • Is the iMESH Tacker sterile and single-use?

    Yes, the device is supplied as a sterile, single-use implant. It should not be reused and must be stored in a controlled environment.

  • Does the iMESH Tacker have FDA clearance?

    The iMESH Tacker has received FDA 510(k) clearance (K153202) as substantially equivalent to a predicate device.

  • Is the iMESH Tacker MRI safe?

    No, the iMESH Tacker is not MRI safe and should not be exposed to MRI environments.