The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Smartstitch Suture Device.
| Device ID | K070671 |
| 510k Number | K070671 |
| Device Name: | OPUS SMARTSTITCH SUTURE DEVICE |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-04-06 |
| Summary: | summary |