Auto Suture Disposable Endoscopic Specimen Pouch

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

510(k) Number

K922123 ↗

FDA Product Code

GCI

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

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 types of endoscopic procedures is this specimen pouch designed for, and why is it considered single-use?

  This pouch is specifically designed for containment and transport of specimens during minimally invasive endoscopic procedures in gastroenterology and urology. It is classified under the FDA’s product code GCI, which covers laryngoscopes and endoscopes, and is intended for one-time use to ensure sterility and prevent cross-contamination between patients. The single-use nature is critical for maintaining hygiene standards in sterile procedures.

• How should I store this pouch to ensure it remains sterile before use?

  The pouch must be stored according to the manufacturer’s guidelines to preserve sterility. Since it is sterile upon packaging, it should remain in its original, unopened packaging until ready for use. Avoid exposure to moisture, heat, or direct sunlight, and keep it in a clean, dry environment to prevent contamination.

• Is this pouch compatible with all endoscopic specimen types, or are there specific considerations?

  The pouch is designed for general use in endoscopic specimen containment and transport, including procedures in gastroenterology and urology. While it is not limited to specific specimen types, its primary purpose is to safely collect and transport excised tissue or specimens without leakage. Always follow facility protocols for handling and labeling specimens post-procedure.

• What regulatory pathway was followed for this device, and how does that affect its use?

  This device received FDA 510(k) clearance (K922123) under the classification for laryngoscopes and endoscopes (product code GCI), demonstrating it is substantially equivalent to a legally marketed predicate device. The clearance confirms it meets FDA safety and effectiveness requirements for its intended use in endoscopic procedures, ensuring compliance with U.S. regulatory standards.