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Minimesh Polypropylene Mesh

by Mpathy Medical Devices, Ltd.

510(k) K041632

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 NumberK041632 Date17 Nov 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1481-2012 FDA Not yet classified initiated 2 Mar 2012 on shared 510(k) K041632

    Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size as 16x11 cm, however, the correct size is actually 14x15 cm. It is important to note that both the product and box labels were correct.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
OTO
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Minimesh Polypropylene Mesh is a synthetic, surgical mesh classified under FDA code 878.3300 as a urogynecologic device for transabdominal repair of apical vaginal and uterine prolapse. Constructed from knitted monofilaments of extruded polypropylene, it provides durable support for fascial deficiencies and hernia repair, offering strength and flexibility to withstand physiological stress.

This device is intended for single-use in surgical settings and is supplied sterile. It features a warp-knit design, allowing for custom sizing and shaping without unraveling. Authorized under FDA 510(k) clearance (K041632), it adheres to regulatory standards for synthetic surgical meshes in urogynecologic applications, with no third-party reprocessing indicated.

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