Auto Suture Surgiport Tissue Grip Disposable Sleev

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

510(k) Number

K910921 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

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 Surgiport Tissue Grip Sleeve used for?

  The Surgiport Tissue Grip Sleeve is a laparoscopic accessory designed to provide tissue grip during minimally invasive surgical interventions, specifically for gynecologic procedures.

• How is the Surgiport Tissue Grip Sleeve supplied?

  The device is supplied as a sterile, single-use item, ensuring each procedure uses a new, uncontaminated accessory to maintain sterility and prevent cross-contamination.

• What is the regulatory classification of this device?

  The Surgiport Tissue Grip Sleeve is classified as a Class II medical device under FDA 510(k) clearance K910921 with product code HET, specifically for use with laparoscopes in obstetrics and gynecology.

• Can the Surgiport Tissue Grip Sleeve be reused?

  No, this device is designed for single-use only. Reusing it could compromise sterility and potentially lead to infection or device failure, as it's not manufactured to withstand multiple procedures.