The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Bipolar Electrosurgery System.
| Device ID | K031029 |
| 510k Number | K031029 |
| Device Name: | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM |
| Classification | Electrode, Electrosurgical, Active, Urological |
| 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 | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-06-19 |
| Summary: | summary |