The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ambient Kvac Wand With Integrated Finger Switches (ambient Kvac Ifs), Kvac Integrated Cable Wand (kvac Icw).
| Device ID | K162126 |
| 510k Number | K162126 |
| Device Name: | Ambient KVac Wand With Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Ashley M. Johnson |
| Correspondent | Ashley M. Johnston ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470000290 | K162126 | 000 |
| 00817470000252 | K162126 | 000 |