The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Smartstich Suture Device With Perfectpasser Connector.
| Device ID | K062244 |
| 510k Number | K062244 |
| Device Name: | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ARTHROCARE CORP. 27130 A PASEO ESPADA SUITE 1427 San Juan Capistrano, CA 92675 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORP. 27130 A PASEO ESPADA SUITE 1427 San Juan Capistrano, CA 92675 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-03 |
| Decision Date | 2006-10-02 |
| Summary: | summary |