Auto Suture Modified Linear Stapler

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

510(k) Number

K952239 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

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

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

• What is the primary purpose of the Auto Suture Modified Linear Stapler?

  This device is intended for use in general and plastic surgery procedures to facilitate the approximation and closure of tissue.

• Is this device considered an implantable product?

  Yes, the Auto Suture Modified Linear Stapler is classified as an implantable staple device, meaning it is designed to be used for internal tissue closure during surgical interventions.

• What is the regulatory status of this device?

  The Auto Suture Modified Linear Stapler is authorized under FDA 510(k) clearance K952239, which indicates it has been found substantially equivalent to legally marketed predicate devices.