Auto Suture Titanium Hemostatic Clip

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

510(k) Number

K853650 ↗

FDA Product Code

FZP

Device Class

Class II

Regulation

21 CFR Part 878.4300

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 Titanium Hemostatic Clip used for?

  The Auto Suture Titanium Hemostatic Clip is designed specifically for hemostasis—stopping blood flow—during surgical procedures. It securely occludes blood vessels to prevent postoperative hemorrhage, making it ideal for general and plastic surgery where precise vascular control is critical. The titanium construction ensures durability and biocompatibility as an implantable device.

• How is the Auto Suture Titanium Hemostatic Clip supplied and what sterility status does it have?

  This device is supplied as a single-use, sterile product, packaged to maintain sterility until use. It must be handled with sterile technique to preserve its integrity, adhering to standard surgical instrument protocols. The sterility is verified through manufacturer testing and packaging standards compliant with FDA requirements for Class II devices.

• Are these clips reusable or intended for single-use only?

  The Auto Suture Titanium Hemostatic Clip is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or hemostatic performance. Single-use ensures patient safety and compliance with surgical best practices.

• What sizes or models are available for the Auto Suture Titanium Hemostatic Clip?

  This device comes in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. Examples include FEI numbers like 3003495548, 3021194552, 1018233, and others listed under the product code FZP. The specific size should be selected based on the vessel diameter and surgical requirements, with the manufacturer providing detailed sizing charts for reference.

• How should the Auto Suture Titanium Hemostatic Clip be stored to maintain functionality?

  Storage must follow standard surgical instrument protocols to preserve sterility and functionality. The device should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or exposure to moisture, as this could compromise the clip’s integrity or sterility before use.