The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ambient Hipvac 50 Wand With Integrated Finger Switches.
| Device ID | K161481 |
| 510k Number | K161481 |
| Device Name: | Ambient HipVac 50 Wand With Integrated Finger Switches |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 |
| Contact | Ashley M. Johnston |
| 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 | 2016-05-31 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556614686 | K161481 | 000 |