REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 is an FDA 510(k)-cleared medical device (K030170) manufactured by Opus Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2003. Regulation: 8.