Auto Suture Modified Endo Stream Suc./Irri. Device

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

510(k) Number

K905426 ↗

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 primary purpose of the Auto Suture Modified Endo Stream Suturing/Irrigating Device in gynecological procedures?

  This device is designed specifically for endoscopic suturing and irrigation within the female reproductive system during minimally invasive gynecological surgeries. It combines suturing capabilities with irrigation functions to help surgeons approximate tissues more precisely and manage fluids efficiently, which can reduce operative time and improve surgical outcomes.

• Is the Auto Suture Modified Endo Stream Suturing/Irrigating Device intended for reuse, or is it single-use only?

  The device is explicitly intended for single-use only, as stated in its regulatory documentation. It is supplied sterile and must be handled using aseptic techniques to maintain sterility, ensuring patient safety during surgical procedures.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The device received FDA 510(k) clearance (K905426) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a predicate device already on the market. This clearance confirms its compliance with FDA standards for laparoscopic gynecologic accessories, but it does not imply any specific clinical indication—only that it meets regulatory requirements for design and safety as classified under FDA regulation 884.1720 (Class II).

• Are there any specific storage instructions provided for this device in the regulatory records?

  The regulatory records for this device do not specify storage conditions beyond the standard requirement for sterile, single-use medical devices. Since it is supplied sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use, following general best practices for surgical instruments.