Prolex Mesh

by Advanced Surgical Innovations, Inc.

510(k) K960219

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

510(k) K960219↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK960219	Date15 Mar 1996Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K960219
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, 20 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 Prolex Mesh is a surgical mesh device classified under the nomenclature for Mesh, Surgical, Polymeric. It is designed to provide structural support in soft tissue repair, particularly in hernia and plastic surgery applications, by reinforcing weakened or damaged tissues to promote healing and prevent recurrence of defects.

This device is supplied as a sterile, single-use implant intended for use in operating room settings. It is regulated under FDA 510(k) clearance (K960219) and falls under product code FTL, adhering to special controls for Class II devices. The mesh is available in various sizes and configurations, as referenced in the regulatory filings, and must be handled and stored according to manufacturer guidelines to maintain sterility and integrity prior to use.