Reusable SmartStitch Suture Device, Models OM-8007, OM-8500

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

510(k) Number

K030170 ↗

FDA Product Code

OCW

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Opus Magnum Knotless Anchor With Inserter Handle

  Class II

  FDA 510(k) K042914 Active Cleared 12 Nov 2004

• Opus Magnum Implant System, Model Om-1500

  Class II

  FDA 510(k) K031083 Active Cleared 12 Jun 2003

• F1 Diode Laser System

  Class II

  FDA 510(k) K030235 Active Cleared 23 Apr 2003

• Opus Magnum Anchor & Inserter

  Class II

  FDA 510(k) K012125 Active Cleared 17 Sep 2001

• Opus Speedstitch Suture Device

  Class II

  FDA 510(k) K042031 Active Cleared 19 Oct 2004

• Smartstitch M-Connector, Model Om-8005; Smartstitch Actuation Handle, Model Om-8500; and Smartstitch Suture Cartridge

  Class II

  FDA 510(k) K023843 Active Cleared 14 Feb 2003

See all devices from Opus Medical, Inc. →

• What is the Reusable SmartStitch Suture Device used for?

  It is an Endoscopic Tissue Approximation Device designed for use in endoscopic and other limited access procedures. It is indicated to place USP size #2 braided polyester suture through soft tissue when used with an OM-8007 M-Connector, supporting tissue approximation in gastroenterology and urology specialties.

• How is the device supplied and prepared for use?

  The device is supplied non-sterile and must be reprocessed before each use. It does not come sterile from the manufacturer, so proper cleaning, disinfection, and sterilization according to institutional protocols are required prior to clinical application.

• Is the SmartStitch Suture Device single-use or reusable?

  It is a reusable device, as indicated by its name and classification. However, because it is supplied non-sterile, each use cycle must include appropriate reprocessing to ensure safety and performance before subsequent patient applications.

• What suture material and size does it require?

  The device is designed to work with USP size #2 braided polyester suture, which is not supplied with the device. Users must source this specific suture type separately and ensure compatibility with the OM-8007 M-Connector for proper function.

• What regulatory pathway did this device follow for market clearance?

  The device received FDA 510(k) clearance under number K030170, with a decision date of July 28, 2003. It was cleared as substantially equivalent to a predicate device and is classified as a Class II medical device under regulation 876.1500, with a traditional clearance type and product code OCW.