The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare System 15000 Controller, Arthrowands.
| Device ID | K093165 |
| 510k Number | K093165 |
| Device Name: | ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-06 |
| Decision Date | 2009-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010625076 | K093165 | 000 |
| 03596010625052 | K093165 | 000 |
| 03596010625069 | K093165 | 000 |
| 03596010625083 | K093165 | 000 |
| 03596010625090 | K093165 | 000 |
| 03596010625106 | K093165 | 000 |
| 03596010625113 | K093165 | 000 |
| 03596010625120 | K093165 | 000 |
| 03596010625137 | K093165 | 000 |
| 03596010625144 | K093165 | 000 |
| 03596010648112 | K093165 | 000 |
| 03596010625045 | K093165 | 000 |