Auto Suture Absorbable Fascia Surgical Stapler

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

510(k) Number

K890270 ↗

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

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• What is the Auto Suture Absorbable Fascia Surgical Stapler used for?

  This device is designed for fascia closure in general and plastic surgery procedures, functioning as an implantable staple that absorbs over time to support tissue healing.

• How is the Auto Suture Absorbable Fascia Surgical Stapler supplied and is it reusable?

  The stapler is supplied as a single-use device only, meaning it is intended for one procedure and one patient, then discarded to ensure sterility and prevent cross-contamination.

• What regulatory clearance does the Auto Suture Absorbable Fascia Surgical Stapler have?

  It received FDA 510(k) clearance under number K890270 on March 17, 1989, based on substantial equivalence to a legally marketed device, and is regulated as a Class II medical device.