The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand.
| Device ID | K011083 |
| 510k Number | K011083 |
| Device Name: | ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-10 |
| Decision Date | 2001-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470001693 | K011083 | 000 |
| 00817470000917 | K011083 | 000 |
| 00817470000122 | K011083 | 000 |
| 00817470000115 | K011083 | 000 |
| 00817470000030 | K011083 | 000 |