# K162074: Werewolf RF20000 Controller, FLOW 50 Wand

- Pathway: 510(k) (Special)
- Applicant: ArthroCare Corporation
- Decided: Aug 22, 2016 after 26 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: 14 generations back to K011083 (2001). 28 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143235: RF20000a Controller, FLOW 50 Wand, ArthroCare Corporation (2015) Summary page 5.

## Most influential descendants
- K183346: FLOW 90 Wand (2019), 2 descendants of its own
- K240964: FLOW 90? Wand (2024), 1 descendant of its own
- K254122: FLOW FLEXTEND Wand (72290039) (2026), 0 descendants of its own

## Indications for use
The Werewolf Coblation System, comprised of the FLOW 50 Wand and the RF20000 Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: Ablation/Debridement All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Tendon Excision/Resection Labrum Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon Hip Acetabular Labrum Capsular Release Cartilage Flaps Knee ACL/PCL Notchplasty Meniscal Cystectomy Discoid Meniscus Lateral Release Meniscectomy Villusectomy Shoulder Acromioplasty Subacromial Decompression Frozen Shoulder Release Glenoid Labrum Wrist Triangular Fibrocartilage (TFCC)

Source page: https://510kreport.com/device/K162074
Methodology: https://510kreport.com/methodology