Endoscopic Ligation Device, Ligator Handle, Ligator Cartridge

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

510(k) Number

K950126 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Glasser Suture Needle

  Class II

  FDA 510(k) K935878 Active Cleared 9 Feb 1994

• Advanced Surgical, Inc. Cannula Cleaning Device and Accessories

  Class II

  FDA 510(k) K933812 Active Cleared 13 Dec 1993

• Laparoscopic Covered Surgical Retractor

  Class II

  FDA 510(k) K933497 Active Cleared 12 May 1994

• Laparoscopic Surgical Retractor

  Class II

  FDA 510(k) K933032 Active Cleared 9 Sep 1993

• Srugical Retractor, Modification

  Class II

  FDA 510(k) K933049 Active Cleared 24 Aug 1993

• Knot Pusher

  Class II

  FDA 510(k) K924728 Active Cleared 29 Dec 1992

See all devices from Advanced Surgical, Inc. →

• What is the endoscopic ligation device used for?

  The endoscopic ligation device is used to place ligatures during endoscopic procedures. It consists of a ligator handle and ligature cartridge designed specifically for endoscopic ligation applications, enabling clinicians to secure tissue internally via endoscope.

• How is the endoscopic ligation device supplied?

  The device is supplied as a system comprising both a ligator handle and a ligature cartridge. These components are designed to work together for use in endoscopic settings, ensuring compatibility and proper function during ligation procedures.

• Is the endoscopic ligation device reusable or single-use?

  The device data does not specify whether the endoscopic ligation device is reusable or single-use. Since no information about reprocessing, sterilization instructions, or reuse limitations is provided in the source material, its intended use duration cannot be determined from the available facts.

• What regulatory pathway was used for the endoscopic ligation device?

  The endoscopic ligation device received FDA 510(k) clearance under submission number K950126. It was determined to be substantially equivalent to a predicate device, with a traditional clearance type and product code GCJ, as indicated in the authorization details.

• Which advisory committees reviewed the endoscopic ligation device?

  The device was reviewed by the Gastroenterology and Urology advisory committees, as indicated by the advisory committee description and the 'GU' designation. The review advisory committee field also lists 'SU', which may reflect a subcommittee or updated classification during the 510(k) process.