Auto Suture Premium Plus CEEA Disposable Stapler

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

510(k) Number

K020804 ↗

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 Premium Plus CEEA Disposable Stapler used for?

  This device is designed for surgical anastomosis, creating secure tissue-to-tissue connections in the alimentary tract. It facilitates wound closure during open or minimally invasive procedures, including end-to-end, end-to-side, and side-to-side anastomoses. The circular stapling mechanism approximates and seals tissue edges to ensure a stable closure.

• How is the Auto Suture Premium Plus CEEA Stapler supplied, and is it reusable?

  The device is supplied sterile and intended for single-use only. It is classified as a disposable medical device, meaning it is not meant for reprocessing or reuse. This ensures patient safety and maintains device performance for each surgical procedure.

• Can this stapler be used in an MRI environment?

  No, the Auto Suture Premium Plus CEEA Stapler contains metallic components that make it MRI-unsafe. It must only be used in non-MRI environments to avoid interference or safety risks during imaging procedures.

• What sizes or models are available for this stapler?

  The device is available in multiple registration numbers (e.g., 3011052945, 3006451981), which likely correspond to different sizes or configurations. These variations are intended to accommodate various surgical needs for anastomosis in the alimentary tract. For precise sizing, refer to the manufacturer’s specifications or consult surgical guidelines.

• How should the Auto Suture Premium Plus CEEA Stapler be stored?

  Since the device is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment protected from contamination. Exposure to moisture, extreme temperatures, or direct sunlight should be avoided to preserve sterility and functionality until use.