# K053297: Arthrocare 8000S Coblator Surgery System

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Dec 6, 2005 after 11 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001588 (2000). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20, Arthrocare Corp. (2000) Summary page 1.

## Most influential descendants
- K060823: Arthrocare Wands (2006), 16 descendants of its own
- K063172: Arthrocare Cavity Spinewand (2007), 12 descendants of its own
- K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 (2010), 11 descendants of its own
- K142480: OsteoCool V-2 RF Ablation System (2015), 9 descendants of its own
- K152057: OsteoCool V-3 RF Ablation System (2015), 8 descendants of its own

## Indications for use
The ArthroCare 8000S Coblator Surgery System is intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroseopic, spinal, and neurological procedures.

Source page: https://510kreport.com/device/K053297
Methodology: https://510kreport.com/methodology