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Contour Midface Opposing Uni-Directional Threads

by Surgical Specialties Corp United States 510(k)

510(k) K050548 Product code GAW

Overview

This device is a suture, nonabsorbable, synthetic, polypropylene surgical strand. It consists of clear, sterile, polypropylene material with a uni-directional-barbed design and a smooth center section.

It is supplied in USP size 2-0 with a 45cm length. The device is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. It is classified as Class II under product code GAW with FDA 510(k) clearance K050548.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050548 Date1 Apr 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
GAW
Device Class
Class II
Regulation
21 CFR Part 878.5010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS device used for?

    It is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position, providing structural support through its uni-directional-barbed polypropylene design and smooth center section.

  • How is the CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS supplied and what are its specifications?

    It is supplied as a sterile, nonabsorbable, synthetic polypropylene suture strand in USP size 2-0 with a 45cm length, featuring a uni-directional-barbed design and a smooth center section for tissue engagement and minimal trauma.

  • Is the CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS device reusable or single-use?

    As a sterile suture implant intended for surgical placement, it is designed for single-use only; re-use would compromise sterility, material integrity, and patient safety, and is not supported by its design or labeling.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K050548 24 fields · synced 22 Oct 2026