The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Smartstitch Perfectpasser System.
| Device ID | K123268 |
| 510k Number | K123268 |
| Device Name: | SMARTSTITCH PERFECTPASSER SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-19 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470007442 | K123268 | 000 |
| 20817470001116 | K123268 | 000 |
| 00817470001679 | K123268 | 000 |
| 00817470005714 | K123268 | 000 |
| 20817470005800 | K123268 | 000 |
| 00817470005813 | K123268 | 000 |
| 20817470005824 | K123268 | 000 |
| 00817470005837 | K123268 | 000 |
| 00817470005844 | K123268 | 000 |
| 00817470005912 | K123268 | 000 |
| 00817470006971 | K123268 | 000 |
| 00817470007381 | K123268 | 000 |
| 20817470007392 | K123268 | 000 |
| 00817470007404 | K123268 | 000 |
| 20817470007415 | K123268 | 000 |
| 00817470007428 | K123268 | 000 |
| 20817470007439 | K123268 | 000 |
| 00817470001105 | K123268 | 000 |