Skip to content

Refine Support System, Model 100.0100

by Alure Medical, Inc.

510(k) K092538

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 NumberK092538 Date5 Mar 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  • Withdrawn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, 6 Oct 2026

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

The Refine Support System, Model 100.0100, is a surgical mesh device for soft tissue reinforcement in plastic or reconstructive procedures. It comprises a non-absorbable mesh implant featuring suture tails with integrated barbs for tissue securement, paired with a delivery system.

The device is supplied as a single unit and is intended for use in general and plastic surgery applications. It is classified as a Class 2 device with the regulation number 878.3300, and has been found to be substantially equivalent. The device has been assigned the product code FTL.

Other devices from Alure Medical, Inc.

Questions

AI-generated answers, 6 Oct 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 Refine Support System Model 100.0100 used for?

    The Refine Support System Model 100.0100 is a surgical mesh device designed for soft tissue reinforcement in plastic or reconstructive procedures. It consists of a non-absorbable mesh implant with suture tails featuring integrated barbs for secure tissue placement.

  • How is the Refine Support System supplied?

    The device is supplied as a single unit, which includes both the non-absorbable mesh implant and the delivery system. This complete package is intended for use in general and plastic surgery applications.

  • Is the Refine Support System reusable or single-use?

    The device is supplied as a single unit, indicating it is designed for single-use. This ensures sterility and optimal performance for each procedure, as reusing medical devices could compromise their integrity and safety.

  • What is the regulatory classification of the Refine Support System?

    The Refine Support System Model 100.0100 is classified as a Class 2 device with regulation number 878.3300 and product code FTL. It has been found to be substantially equivalent through the FDA 510(k) process with K number K092538.