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PolySyn Surgical Suture

by Surgical Specialties Corp United States 510(k)

510(k) K141625 Product code GAM

Overview

PolySyn Surgical Suture is a synthetic absorbable suture made of polyglycolic acid (PGA). It is classified as a suture, absorbable, synthetic, polyglycolic acid device under FDA regulation number 878.4493.

The device is supplied in USP sizes 7-0 through 10-0 and is intended for use in general and plastic surgery procedures. It is a single-use, sterile device that has received FDA 510(k) clearance (K141625) as substantially equivalent to predicate devices.

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 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK141625 Date18 Jul 2014ClearedStatusActive

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
GAM
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Surgical Specialties Corp

See all devices from Surgical Specialties Corp →

Questions

  • What is PolySyn Surgical Suture made of and what is its intended use?

    PolySyn Surgical Suture is made of polyglycolic acid (PGA), a synthetic absorbable material, and is intended for use in general and plastic surgery procedures as a suture material to approximate and ligate soft tissues.

  • What sizes is PolySyn Surgical Suture available in and how is it supplied?

    PolySyn Surgical Suture is supplied in USP sizes ranging from 7-0 to 10-0, and is provided as a sterile, single-use device ready for immediate surgical application.

  • Is PolySyn Surgical Suture sterile and designed for single use only?

    Yes, PolySyn Surgical Suture is supplied in a sterile condition and is designated for single-use only, meaning it should not be reprocessed or reused after initial application to prevent infection and ensure performance integrity.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K141625 24 fields · synced 22 Oct 2026