Ussc Monofilament Polysorb Suture

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

510(k) Number

K945285 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SN

• 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

See all devices from United States Surgical, A Division of Tyco Healthc →

• What is the USSC MONOFILAMENT POLYSORB SUTURE used for?

  This device is a synthetic absorbable suture made of polyglycolic acid, designed for use in general and plastic surgery procedures, as indicated in the device description and advisory committee classification.

• How is the USSC MONOFILAMENT POLYSORB SUTURE supplied and is it reusable?

  The suture is supplied sterile and intended for single-use only, as explicitly stated in the description, meaning it should not be reprocessed or reused after initial use.

• What regulatory pathway was used for the USSC MONOFILAMENT POLYSORB SUTURE?

  The device is regulated under FDA 510(k) clearance with K-number K945285, classified as a Class II device under regulation number 878.4493, based on traditional submission and substantial equivalence for some indications.