Arthrocare System 12000
510(k) K071709
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071709 | Date7 Aug 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Arthrocare System 12000 is an electrosurgical device that utilizes radiofrequency energy to treat tissue. It functions by passing energy through a conductive solution, such as normal saline or Ringer's lactate, which is applied in close proximity to or in contact with the target tissue.
This system operates by forming a thin layer of conductive solution between the active and return electrode elements to facilitate ablation. The device received FDA 510(k) clearance on August 7, 2007, under the reference number K071709.
Other devices from ArthroCare Corporation
Questions
AI-generated answers, 21 Sep 2026
How does the Arthrocare System 12000 function?
The system operates by utilizing radiofrequency energy passed through a conductive solution, such as normal saline or Ringer's lactate. This process creates a thin layer of conductive fluid between the active and return electrodes to facilitate the ablation of target tissue.
What is the regulatory status of this device?
The Arthrocare System 12000 received FDA 510(k) clearance on August 7, 2007, under the reference number K071709. This indicates the device was determined to be substantially equivalent to legally marketed predicate devices.
What types of conductive solutions are compatible with this system?
The device is designed to function with conductive solutions applied in close proximity to or in contact with the target tissue, specifically identifying normal saline or Ringer's lactate as appropriate mediums for energy transmission.