LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K254122

    Validate with FDA (Live)

    Device Name
    FLOW FLEXTEND Wand (72290039)
    Manufacturer
    ArthroCare Corporation
    Date Cleared
    2026-03-30

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K162074,K003893,K240964
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K162074, K003893

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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: 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.

    Hip
    Excision/Resection: Acetabular Labrum.

    Knee
    Ablation/Debridement: ACL/PCL, Notchplasty.
    Excision/Resection: Capsular release, Cartilage Flaps, Discoid Meniscus, Lateral release, Meniscal Cystectomy, Meniscectomy, Villisectomy.

    Shoulder
    Ablation/Debridement: Subacromial Decompression.
    Excision/Resection: Frozen Shoulder Release, Glenoid Labrum.

    Wrist
    Excision/Resection: Triangular Fibrocartilage.

    Device Description

    The FLOW FLEXTEND Wand is a single use, bipolar, radiofrequency (RF) electrosurgical device designed for specific indications in orthopedic and arthroscopic procedures. The wand is designed for compatibility with the existing hardware and software of the WEREWOLF Controllers (WEREWOLF COBLATION System (K162074), WEREWOLF COBLATION System (K192027), WEREWOLF+ COBLATION System (K210423), and the INTELLIO SHIFT System (P/N 72290150). No design changes have been made to the WEREWOLF COBLATION System or INTELLIO SHIFT System to support the use of the FLOW FLEXTEND Wand.

    The FLOW FLEXTEND Wand consists of a handle with integrated finger switches, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle/handpiece and connect to the WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively.

    • The integrated cable is compatible with WEREWOLF and INTELLIO SHIFT Systems (Controllers); the cable connector is specific and proprietary to the compatible systems and is designed so the Wand cannot be plugged into any other commercial system.

    • The integrated suction tubing is compatible with Integrated Fluid Control Module (FLOW-IQ Pump) of WEREWOLF and INTELLIO SHIFT Controllers and allows connection with saline source. The suction tubing has color-coded and keyed inserts that correspond to matching receptacles on the FLOW-IQ Pump so the tubing cannot be connected incorrectly.

    The Wand may be activated using integrated finger switches directly on the handle or by using the compatible Foot Control system accessory for each Controller. The Wand is provided sterile (via ethylene oxide) and is single use only. When used with both the WEREWOLF and INTELLIO SHIFT systems the wand is designed to work in ablation mode for tissue removal, resection, and in coagulation mode to create hemostasis of blood vessels encountered during arthroscopic and orthopedic surgery. The effect is dependent on the selected Controller settings.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1