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Hydrocoat Mesh

by Promethean Surgical Devices, Inc.

510(k) K090271

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 NumberK090271 Date14 Jan 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  • Withdrawn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, 25 Sep 2026

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

Hydrocoat Mesh is a surgical polymeric mesh device. It is a thin, flat sheet fabricated from polypropylene fiber.

The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. It is regulated under FDA 510(k) clearance K090271, product code FTL, regulation number 878.3300, and device class 2.

Questions

AI-generated answers, 25 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 Hydrocoat Mesh used for?

    Hydrocoat Mesh is a surgical polymeric mesh device intended for use in general and plastic surgery procedures as a thin, flat sheet fabricated from polypropylene fiber.

  • Is Hydrocoat Mesh supplied sterile or non-sterile?

    Hydrocoat Mesh is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user, as specified in the device description.

  • What material is Hydrocoat Mesh made from?

    Hydrocoat Mesh is fabricated from polypropylene fiber, forming a thin, flat sheet as described in its specifications.

  • How is Hydrocoat Mesh regulated?

    Hydrocoat Mesh is regulated under FDA 510(k) clearance K090271, product code FTL, regulation number 878.3300, and device class 2.