# K080282: Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00;

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Feb 15, 2008 after 11 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K011083 (2001). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053567: Athrocare Topaz Arthrowands, Arthrocare Corp. (2006) Summary page 1.
- K071709: Arthrocare System 12000, Arthrocare Corp. (2007) Summary page 1.

## Most influential descendants
- K140521: Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch (2014), 0 descendants of its own

## Recalls of this device
- Mar 3, 2016 · Class II · Z-1321-2016: During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.

## Indications for use
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: * Fasciotomy — Foot * Synovectomy — Foot * Tendonotomy — Knee, Wrist, Elbow, Ankle, Shoulder, Foot * Rotator Cuff Tendonotomy — Shoulder * Capsulotomy — Foot

Source page: https://510kreport.com/device/K080282
Methodology: https://510kreport.com/methodology