Skip to content

Optilene Mesh

by Aesculap, Inc.

510(k) K061704

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 NumberK061704 Date19 Jul 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  • Withdrawn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, 27 Sep 2026

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

Optilene Mesh is a surgical, polymeric mesh implant designed for the reinforcement of connective tissue structures. It is constructed from monofilament polypropylene knitted into a thin, elastic, and shape-stable configuration.

This device is indicated for use in surgical procedures such as inguinal and incisional hernia repair. It has received FDA 510(k) clearance as a Class 2 device under product code FTL.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Questions

AI-generated answers, 27 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 primary clinical use for Optilene Mesh?

    Optilene Mesh is indicated for the reinforcement of connective tissue structures during surgical procedures, specifically including the repair of inguinal and incisional hernias.

  • What material is used to construct this surgical mesh?

    The device is constructed from monofilament polypropylene, which is knitted into a thin, elastic, and shape-stable configuration designed for surgical implantation.

  • What is the regulatory status of this device?

    Optilene Mesh has received FDA 510(k) clearance as a Class 2 medical device under product code FTL, which pertains to surgical, polymeric mesh implants.