# K082980: Arthrocare Arthrowands

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Nov 5, 2008 after 30 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K011083 (2001). 23 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082323: Arthrocare Arthrowands, Arthrocare Corp. (2008) Summary page 1.

## Most influential descendants
- K083306: Modification to Arthrocare Arthrowands (2008), 14 descendants of its own
- K143235: RF20000a Controller, FLOW 50 Wand (2015), 4 descendants of its own
- K120791: Ambient Turboflash 90 Ifs (2012), 4 descendants of its own
- K162074: Werewolf RF20000 Controller, FLOW 50 Wand (2016), 3 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0621-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0618-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0619-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0620-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0615-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0616-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0617-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0622-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0623-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0624-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0625-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0626-2012: Product is being removed from the field due to an over-label issue.

## Indications for use
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement ACL/PCL — Knee Acromioplasty — Shoulder Articular Cartilage — All Joints Bursectomy — All Joints Chondroplasty — All Joints Facia — All Joints Ligament — All Joints Notchplasty — Knee Scar Tissue — All Joints Soft Tissue — All Joints Subacromial Decompression — Shoulder Synovectomy — All Joints Tendon — All Joints Excision and Resection Acetabular Labrum — Hip Articular Labrum — All Joints Capsule — All Joints Capsular Release — Knee Cartilage Flaps — Knee Cysts — All Joints Discoid Meniscus — Knee Frozen Shoulder Release — Shoulder Glenoidale Labrum — Shoulder Lateral Release — Knee Ligament — All Joints Loose Bodies — All Joints Meniscal Cystectomy — Knee Meniscectomy — Knee Plica Removal — All Joints Scar Tissue — All Joints Soft Tissue — All Joints Synovial Membrane — All Joints Tendon — All Joints Triangular Fibrocartilage (TFCC) — Wrist Villusectomy — Knee Coagulation ACL/PCL — Knee Articular Cartilage — All Joints Carpal Ligaments — Wrist Glenohumeral Capsule — Shoulder Ligament — All Joints Medial Retinaculum — Knee Rotator Cuff — Shoulder Tendon — All Joints Wrist Tendons — Wrist

Source page: https://510kreport.com/device/K082980
Methodology: https://510kreport.com/methodology