The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139,72202141, 72202143, 72202144.
| Device ID | K090393 |
| 510k Number | K090393 |
| Device Name: | ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556572955 | K090393 | 000 |
| 00885554017298 | K090393 | 000 |
| 00885554016888 | K090393 | 000 |
| 03596010625038 | K090393 | 000 |
| 03596010624949 | K090393 | 000 |