The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Smartstitch M-connector, Model Om-8700; Needle Cassette, Om-8750; Autocuff System Instrument Set, Om-9070.
| Device ID | K033317 |
| 510k Number | K033317 |
| Device Name: | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz 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 | 2003-10-15 |
| Decision Date | 2003-12-30 |