# K140521: Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch

- Pathway: 510(k) (Special)
- Applicant: ArthroCare Corporation
- Decided: Jun 10, 2014 after 98 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: 9 generations back to K011083 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080282: Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00;, Arthrocare Corp. (2008) Summary page 1.

## Indications for use
The TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch is indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Procedure — Body Structure Fasciotomy — Foot Synovectomy — Foot Tendonotomy — Knee, Wrist, Elbow, Ankle, Shoulder, Foot Rotator Cuff Tendonotomy — Shoulder Capsulotomy — Foot

Source page: https://510kreport.com/device/K140521
Methodology: https://510kreport.com/methodology