Polysorb II Coated Synthetic Absorbable Suture

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953869 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

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• What is Polysorb II Coated Synthetic Absorbable Suture used for?

  It is indicated for use in soft tissue approximation. The suture is designed to hold tissues together during the healing process.

• How is the suture supplied?

  The suture is supplied sterile and is intended for single use. It is important to follow manufacturer guidelines for proper storage and handling to maintain sterility.

• What are the material specifications of the suture?

  The suture is a flexible strand composed of homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide. It meets United States Pharmacopeia (U.S.P.) requirements.

• What is the regulatory status of this device?

  Polysorb II Coated Synthetic Absorbable Suture is regulated under FDA 510(k) clearance and is classified as a Class II medical device.