Smartstitch Suture Device, Model Om-8500

• • Terminated Z-1312-06 FDA Unclassified (pre-2012) ·initiated 28 Jun 2006 ·on shared 510(k) K022229

  The product may lose sterility due to omission of the final pouch seal.

• 2 recalls, same reason

  • Terminated Z-1187-06 FDA Unclassified (pre-2012) ·initiated 7 Jun 2006 ·on shared 510(k) K022229
  • Terminated Z-1186-06 FDA Unclassified (pre-2012) ·initiated 7 Jun 2006 ·on shared 510(k) K022229

  Potential loss of product sterility due to breach of pouch seal.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K022229 ↗

FDA Product Code

OCW

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K042914 Active Cleared 12 Nov 2004

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  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. →