# K162126: Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Sep 29, 2016 after 59 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: 13 generations back to K011083 (2001). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083306: Modification to Arthrocare Arthrowands, Arthrocare Corp. (2008) Summary page 5.

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

Source page: https://510kreport.com/device/K162126
Methodology: https://510kreport.com/methodology