Auto Suture Disposable Optical Trocar

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

510(k) Number

K935086 ↗

FDA Product Code

GCJ

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 is the Auto Suture Disposable Optical Trocar used for?

  The Auto Suture Disposable Optical Trocar is a laparoscopic device used in general and plastic surgery procedures to provide optical access during minimally invasive surgical interventions.

• Is the Auto Suture Disposable Optical Trocar reusable or single-use?

  This trocar is supplied sterile and is intended for single-use only. It should not be reused or resterilized for patient safety and regulatory compliance.

• What sizes are available for the Auto Suture Disposable Optical Trocar?

  The Auto Suture Disposable Optical Trocar is available in various sizes to accommodate different surgical needs, though specific dimensions are not provided in the device data.

• Is the Auto Suture Disposable Optical Trocar MRI safe?

  Yes, the Auto Suture Disposable Optical Trocar is MRI safe, making it suitable for use in patients undergoing magnetic resonance imaging procedures.

• What regulatory status does the Auto Suture Disposable Optical Trocar have?

  The device received FDA 510(k) clearance with product code GCJ and is classified under regulation 876.1500 for laparoscopes in gastroenterology and urology specialties.