# K100353: Spinewand Surgical Device

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: May 13, 2010 after 90 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: 4 generations back to K010811 (2001). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053447: Arthrocare Perc-D Spinewand, Arthrocare Corp. (2005) Summary page 1.
- K030954: Arthrocare Percd Spinewand, Arthrocare Corp. (2003) Summary page 1.
- K020621: Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands, Arthrocare Corp. (2002) Summary page 1.
- K010811: Perc-D Spinewand, Arthrocare Corp. (2001) Summary page 1.

## Most influential descendants
- K132099: Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand (2013), 1 descendant of its own
- K162490: Disc-FX System (2017), 0 descendants of its own
- K150915: Spinaut-P (2016), 0 descendants of its own

## Indications for use
The ArthroCare® Coblator IQTM Perc-D® SpineWand® is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

Source page: https://510kreport.com/device/K100353
Methodology: https://510kreport.com/methodology