The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedstitch Suture Passer; Speedstitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; Speedstitch Needle Loader And Unloader.
| Device ID | K163142 |
| 510k Number | K163142 |
| Device Name: | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader And Unloader |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ArthroCare Corporation 15285 Alton Parkway Suite 200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ArthroCare Corporation 15285 Alton Parkway Suite 200 Irvine, CA 92618 |
| Product Code | GAT |
| Subsequent Product Code | HXK |
| Subsequent Product Code | NBH |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-01-06 |
| Summary: | summary |