The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ciq Controller, Ciq Wands.
Device ID | K123353 |
510k Number | K123353 |
Device Name: | CIQ CONTROLLER, CIQ WANDS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Contact | Mitchell Dhority |
Correspondent | Mitchell Dhority 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 | 2012-10-31 |
Decision Date | 2013-04-05 |
Summary: | summary |