The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000.
| Device ID | K011634 |
| 510k Number | K011634 |
| Device Name: | ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-29 |
| Decision Date | 2001-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470004588 | K011634 | 000 |
| 00817470004274 | K011634 | 000 |
| 00885556618417 | K011634 | 000 |