The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Reusable Smartstitch Suture Device, Models Om-8007, Om-8500.
| Device ID | K030170 |
| 510k Number | K030170 |
| Device Name: | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Contact | James W Hart |
| Correspondent | James W Hart OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-07-28 |
| Summary: | summary |