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Suture Absorbable- Gut

by Surgical Specialties, Inc. United States 510(k)

510(k) K932037

Product code GAR

Overview

Suture Absorbable- Gut is a sterile, single-strand suture designed for reliable soft tissue approximation. It is constructed as a monofilament plain gut suture composed of purified connective tissue (mostly collagen) derived from the serosal layer of beef (bovine) intestines.

It is supplied sterile and intended for single-use in general and plastic surgery procedures. The device is packaged in a solution of 87% isopropanol and 12% water, and is regulated under FDA 510(k) clearance (K932037) as a Class II medical device with product code GAR and regulation number 878.5020.

Summary written by AI from registry data, 21 Sep 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 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932037 Date7 Jan 1994ClearedStatusActive

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 America
  • Active
  • 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
GAR
Device Class
Class II
Regulation
21 CFR Part 878.5020
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Surgical Specialties Corp

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Questions

  • What is Suture Absorbable- Gut used for?

    Suture Absorbable- Gut is designed for reliable soft tissue approximation in general and plastic surgery procedures, providing temporary wound support as it absorbs naturally over time.

  • How is Suture Absorbable- Gut supplied and is it sterile?

    It is supplied sterile in a solution of 87% isopropanol and 12% water, ensuring microbial barrier integrity until point of use, and is intended for single-use only.

  • What material is Suture Absorbable- Gut made from and what is its structure?

    It is constructed as a monofilament plain gut suture composed of purified connective tissue, mostly collagen, derived from the serosal layer of beef (bovine) intestines.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K932037 24 fields · synced 22 Oct 2026