Manufacturer
ArthroCare CorporationFLOW FLEXTEND Wand (72290039)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K254122
- Device name
- FLOW FLEXTEND Wand (72290039)
- Company
- ArthroCare Corporation
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-12-19
- Decision date
- 2026-03-30
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue RepairPain Management
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The FLOW FLEXTEND Wand, used with a qualified controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) Ablation/Debridement Anicular 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. Hip Excision/Resection: Acetabular Labrum. Knee Ablation/Debridement ACL/PCL, Notchplasty. Excision/Resection: Capsular release, Cartilage Flaps, Discoid Meniscus, Lateral release, Meniscal Cystectomy, Meniscectomy, Vilusectomy. Shoulder Ablation/Debridement Subacromial Decompression. Excision/Resection: Frozen Shoulder Release, Glenoid Labrum. Wrist Excision/Resection: Triangular Fibrocartilage.
Intended Use
The FLOW FLEXTEND Wand, used with a qualified controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow), Ablation/Debridement Anicular 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. Hip Excision/Resection: Acetabular Labrum. Knee Ablation/Debridement ACL/PCL, Notchplasty. Excision/Resection: Capsular release, Cartilage Flaps, Discoid Meniscus, Lateral release, Meniscal Cystectomy, Meniscectomy, Vilusectomy. Shoulder Ablation/Debridement Subacromial Decompression. Excision/Resection: Frozen Shoulder Release, Glenoid Labrum. Wrist Excision/Resection: Triangular Fibrocartilage.
Device Description
The purpose of this submission is to obtain clearance for the FLOW FLEXTEND Wand intended to be used with the previously cleared WEREWOLF COBLATION Systems (WEREWOLF COBLATION system (K162074), WEREWOLF COBLATION System (K192027), WEREWOLF+ COBLATION System (K210423) and INTELLIO SHIFT System (K232290).
Summary parsed at:2026-06-19 23:54:02 UTC
Predicate devices
6Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K254122 as a predicate