Auto Suture Surgiwand

• • Ongoing Z-1411-2021 FDA Class II ·initiated 5 Mar 2021

  Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

510(k) Number

K961771 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

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 Auto Suture Surgiwand used for?

  The Auto Suture Surgiwand is designed specifically for the ligation and transection of tissue, enabling surgeons to securely close blood vessels and other anatomical structures during surgical procedures. Its precise and controlled application helps facilitate reliable surgical site closure in general and plastic surgery settings.

• Is the Auto Suture Surgiwand reusable or single-use?

  The Auto Suture Surgiwand is supplied as a reusable surgical instrument. Due to its stainless steel construction, it requires thorough cleaning, sterilization, and maintenance between uses to ensure proper functionality and infection control in sterile operating environments.

• What materials is the Auto Suture Surgiwand made from?

  The Auto Suture Surgiwand is constructed from stainless steel. This material choice ensures durability and compatibility with standard sterilization processes, though it also means the device is not labeled as MRI-safe.

• How is the sterility of the Auto Suture Surgiwand maintained?

  The device itself is not labeled with specific sterility assurances in the provided data. However, as a reusable instrument, its sterility is maintained through proper cleaning, sterilization, and maintenance protocols between uses in a sterile operating environment.

• What regulatory pathway was followed for the Auto Suture Surgiwand?

  The Auto Suture Surgiwand received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. The clearance (K961771) was granted on September 25, 1996, and falls under product code GEI for general and plastic surgery applications.