The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Entec Evac Plasma Wand.
| Device ID | K011279 |
| 510k Number | K011279 |
| Device Name: | ENTEC EVAC PLASMA WAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Contact | Bruce Prothro |
| Correspondent | Bruce Prothro ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-27 |
| Decision Date | 2001-07-19 |