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Modification to: Minimesh Polypropylene Mesh

by Mpathy Medical Devices, Ltd.

510(k) K053361

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 · Special NumberK053361 Date6 Feb 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1481-2012 FDA Not yet classified initiated 2 Mar 2012 on shared 510(k) K053361

    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  • Withdrawn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, 24 Sep 2026

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

This device is a surgical mesh made of polypropylene, intended for use in urogynecologic procedures to treat apical vaginal and uterine prolapse. It is designed to be placed transabdominally to provide support for pelvic organ prolapse repair.

The device is supplied as a sterile, single-use implant. It is authorized under FDA 510(k) clearance (K053361) and is classified as a Class II medical device. It is intended for use in surgical settings by trained healthcare professionals.

Other devices from Mpathy Medical Devices, Ltd.

Questions

AI-generated answers, 24 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 clinical condition is this mesh designed to treat?

    The mesh is intended for urogynecologic procedures that repair apical vaginal and uterine prolapse, providing transabdominal support to restore pelvic organ position.

  • How is the product supplied and what are its sterility requirements?

    It is supplied as a sterile, single‑use implant, meaning each unit is packaged sterile and intended for one procedure only, eliminating the need for re‑sterilization.

  • Can the mesh be reused for multiple patients?

    No. Because it is labeled as a single‑use device, reusing it would compromise sterility and could increase the risk of infection or tissue reaction.

  • What regulatory pathway was used for this device?

    The device received FDA 510(k) clearance (K053361) with a special clearance type, indicating it was found substantially equivalent to a legally marketed predicate.

  • Who is authorized to place this mesh during surgery?

    Placement is intended for trained healthcare professionals in a surgical setting, typically surgeons experienced in urogynecologic and pelvic reconstructive procedures.