The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Opus Speedstitch Suture Device.
| Device ID | K042031 |
| 510k Number | K042031 |
| Device Name: | OPUS SPEEDSTITCH SUTURE DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-28 |
| Decision Date | 2004-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005929 | K042031 | 000 |
| 00817470005905 | K042031 | 000 |
| 20817470005893 | K042031 | 000 |
| 00817470005882 | K042031 | 000 |
| 20817470005879 | K042031 | 000 |
| 00817470005868 | K042031 | 000 |
| 00817470001402 | K042031 | 000 |
| 20817470001048 | K042031 | 000 |
| 00817470001037 | K042031 | 000 |