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Optilene Mesh Lp

by Aesculap, Inc.

510(k) K053158

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 NumberK053158 Date18 Jan 2006ClearedStatusActive

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  • Withdrawn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, 28 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 Optilene Mesh Lp is a mesh implant for reinforcement of connective tissue structures, constructed from monofilament polypropylene knitted to a thin and elastic shape-stable mesh. It is a surgical, polymeric mesh. The device is used for implantation and adapts to the expansions in the connective tissue.

The Optilene Mesh Lp is supplied in various sizes, including 10 x 15 cm. It is classified as a Class II device with special controls, and has been cleared by the FDA. The device is intended for use in inguinal hernia repair, and has a weight to area ratio of 40 g/m2.

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Questions

AI-generated answers, 28 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 Optilene Mesh Lp used for?

    The Optilene Mesh Lp is used for implantation and reinforcement of connective tissue structures, specifically for inguinal hernia repair.

  • What material is the Optilene Mesh Lp made of?

    The Optilene Mesh Lp is constructed from monofilament polypropylene knitted to a thin and elastic shape-stable mesh.

  • Is the Optilene Mesh Lp supplied in different sizes?

    Yes, the Optilene Mesh Lp is supplied in various sizes, including 10 x 15 cm.

  • What is the weight to area ratio of the Optilene Mesh Lp?

    The Optilene Mesh Lp has a weight to area ratio of 40 g/m2.