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Synthetic Absorbable Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130735

by Foosin Medical Supplies Inc., Ltd.

Identifiers

510(k) Number
K130735 FDA 510(k)
FDA Product Code
GAM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4493 FDA 510(k)
Regulation Number
878.4493 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a synthetic absorbable suture, specifically composed of polyglycolic acid, intended for use in general and plastic surgery procedures. It is designed to approximate and ligate soft tissues during surgical intervention, providing temporary wound support until adequate healing occurs.

The suture is supplied sterile and is intended for single-use only. It is regulated as a Class II medical device under FDA 510(k) clearance (K130735) and is indicated for use in general and plastic surgery settings. Storage and handling should follow manufacturer guidelines to maintain sterility and performance prior to use.

Frequently asked questions

What is this suture used for?

This synthetic absorbable suture is intended for use in general and plastic surgery procedures to approximate and ligate soft tissues, providing temporary wound support until adequate healing occurs.

Is this suture sterile and for single-use only?

Yes, the suture is supplied sterile and is designed for single-use only, meaning it should not be resterilized or reused to ensure patient safety and maintain its absorbable properties.

What material is this suture made from?

The suture is composed of polyglycolic acid, a synthetic polymer that is absorbable by the body over time, eliminating the need for suture removal in most cases.

How should this suture be stored before use?

Storage and handling should follow the manufacturer's guidelines to maintain sterility and performance prior to use, as specified in the labeling and instructions for use.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Hydrogel Dressing, Waterproof Wound Plaster, Wound Plaster - Foosin ..., Foosin Medical Supplies Inc., Ltd. G13363 WEGO-PGA Absorbable Surgical ..., About Us | Foosin Medical Supplies Inc., Ltd., Synthetic Absorbable Medical Supply Surgical Suture with Needle, PGA-PDO-PGLA-RPGA, synthetic absorbable surgical sutures - Foosin ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foosin Medical Supplies Inc., Ltd.

Sources (1)

  • FDA 510(k) K130735 24 fields · synced Oct 6, 2026