Medical Device Manufacturer · US , Albuquerque, , NM

Opus Medical, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2001

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Opus Medical, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Dec 30, 2003

SMARTSTITCH M-CONNECTOR, MODEL OM-8700

Gastroenterology & Urology · 76d

Cleared Jul 28, 2003

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

Gastroenterology & Urology · 192d

Cleared Feb 14, 2003

SMARTSTITCH M-CONNECTOR, MODEL OM-8005

Gastroenterology & Urology · 88d

Cleared Sep 06, 2002

SMARTSTITCH SUTURE DEVICE, MODEL OM-8500

Gastroenterology & Urology · 58d