The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Smartstitch M-connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle.
| Device ID | K121306 |
| 510k Number | K121306 |
| Device Name: | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-07-12 |
| Summary: | summary |