SMARTSTITCH SUTURE DEVICE, MODEL OM-8500


Device Classification Name

endoscope and/or accessories

510(k) Number K022229
Device Name SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
Original Applicant
OPUS MEDICAL, INC.
27127 calle arroyo, suite 1924
san juan capistrano, 
CA 
92675

Original Contact james w hart
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 07/10/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls