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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.

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.

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The AVENTIX™ PFX System is an electrosurgical system intended to generate Pulsed Field Energy (PFE) for use with the NOVOCLEAR™ Device. The AVENTIX™ PFX System is indicated for use in small clinics, offices and/or hospital environments.

The NOVOCLEAR™ Device is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including the posterior nasal nerve distribution in patients with chronic rhinitis.

The AVENTIX™ PFX System and NOVOCLEAR™ Device include the following components:

1. NOVOCLEAR™ Device - a single use, hand-held device capable of delivering pulsed field energy (PFE) to targeted tissue. The NOVOCLEAR™ Device consists of a handle, a dome-like electrode and an electrical connector. The dome-like electrode delivers PFE and is angled to approximately 60 degrees, to aid access to the targeted tissue. An electrical connector is used to connect the NOVOCLEAR™ Device to the AVENTIX™ Generator.

2. AVENTIX™ Generator - generates predefined PFE output, which is delivered to the NOVOCLEAR™ Device dome-like electrode tip.

3. AVENTIX™ Controller – Performs validation of the NOVOCLEAR™ Device prior to use, changes the status of the Generator between armed and disarmed, and receives and displays parameters from the generator to the user.

4. Footswitch – for selective activation by the user to initiate PFE output.

The NOVOCLEAR™ Device delivers pulsed field energy (PFE) to soft tissues in the nasal airway, including the posterior nasal nerve distribution. Non-clinical testing was performed to support safety and performance for the labeled use.

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The LYNX◊ COBLATION◊ Laryngeal Wand is indicated for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels for otorhinolaryngology (ENT) procedures of the larynx and trachea.

The LYNX™ COBLATION™ Laryngeal Wand is intended for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology (ENT) procedures.

It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. It is intended to be used with qualified controllers.

The LYNX COBLATION Laryngeal Wand is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) procedures. The device is intended to work with Qualified Controllers (WEREWOLF COBLATION SYSTEM (WEREWOLF ENT and WEREWOLF +). There are no changes to the WEREWOLF Controllers or Irrigation pump for use with LYNX Wand.

The LYNX Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended:

• An integrated suction line allows connection to suction source within the operating environment.
• An integrated saline tube set designed to be compatible with the WEREWOLF flow control module allows connection with saline source within the operating environment.
• An integrated cable compatible with the WEREWOLF controller.

The device operates in Coblation (resection/ablation) and Coagulation (coagulation/hemostasis) modes by using their biopolar configuration to create energy field using a conductive irrigating solution.

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The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

The NanoKnife Generator is part of the NanoKnife System, and is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue, including prostate tissue. Included for use within the NanoKnife System are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue subsequent pairs of probes. Soft tissue (including prostate tissue) between the probes is ablated.

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The BTL-785NEH device has the following indications for use:

The BTL-785NEH with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785NEH with BTL-785-2 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785NEH with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature, for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-5 and BTL-785-4-6 is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-3 and BTL-785-4-4 is intended for dermatological procedures requiring fractional treatment of the skin.

At higher energy levels greater than 62 mJ/pin or microneedle, the use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785NEH with BTL-785-7 Handpiece used with hands-free applicators:

BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8, BTL-785-7-10, BTL-785-7-11 single-use applicators are intended to provide:

• Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:

• Non-invasive temporary reduction of facial wrinkles.

BTL-785-7-9 single-use applicator is intended to:

• Affect the appearance of lax tissue in the submental area.

The BTL-785NEH is a state-of-the-art radiofrequency, ultrasound and electrostimulation platform. The device is comprised of a control unit and applicators. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The device is accompanied by the following applicators:

• BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas.

• BTL-785-2 applicator providing treatment by integration of radiofrequency and ultrasound. Suitable for the treatment of small areas.

• BTL-785-3 applicator providing radiofrequency treatment. The therapy is provided with single use tips only.

• BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial pins. Therapy is provided with single use tips only.

• BTL-785-7 handpiece with hands-free applicators providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout. Muscle workout naturally increases local blood circulation. Suitable for the treatment of face, neck and small and sensitive areas. The therapy is provided with single use electrodes only.

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Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in RF mode are intended for:

• Relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

Q-EP handpiece in cooling mode is intended for:

• Use in dermatologic procedures for the removal of benign lesions of the skin and for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.

Apollo Quattro is a combination stimulator used to relieve pain by applying radio frequency, low frequency, heating, and cooling energy to the affected area.

Apollo Quattro has a Q-EP handpiece, Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, Q-BT handpiece, patch (cleared under K042301), patch cable, funnel hose, and power cable.

The Q-LF, Q-FX, Q-SC, and Q-BT handpieces are used for radio frequency or low frequency output, while the Q-EP handpiece is used for heating or cooling output, or for low frequency when used with the patch and patch cable.

The cooling function of Apollo Quattro is substantially equivalent to the device cleared in K213294. The Apollo Quattro is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin.

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The NeoSculpt Plus is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.

The NeoSculpt Plus is a medical device designed for use by medical professionals in hospital settings. It delivers Radiofrequency (RF) energy to a patient for therapeutic treatment. The system is composed of a main console, one or more RF handpieces that connect to the console via umbilical cables, and neutral electrodes that attach to the patient's skin.

The NeoSculpt Plus provides topical heating to elevate tissue temperature, which can be used to treat various medical conditions, including the relief of pain and muscle spasms and to increase local circulation. The system operates by generating a high-frequency current that flows from the handpiece, through the patient's body (which acts as a resistance), and back to the console via the neutral electrode. This intensive current flow generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.

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The POWERSEAL Open Extended Jaw, Sealer & Divider, Double- Action is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm.

POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments are indicated for use in general surgery and such surgical specialties as urologic, colorectal, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and oophorectomy.

The POWERSEAL Open Extended Jaw has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use POWERSEAL Open Extended Jaw for these procedures.

The POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The jaws of the PSOEJ are designed to work with an electrosurgical unit to seal vessels, and grasp and dissect tissue during open general surgical procedures using radiofrequency (RF) energy, also known as HF energy. A hand-actuated mechanism allows the user to open and close the instrument jaws. The device creates a seal by application of RF energy to vascular structures (vessels, lymphatics) or tissue bundles between the jaws of the device. When the sealing is complete, the user operates a separate control to activate a blade within the device, which divides the tissue along the seal line. The device is supplied sterile and is intended for single use. The POWERSEAL Open Extended Jaw, Sealer and Divider, Double-Action is designed for use with Olympus electrosurgical generators, ESG-400 and ESG-410. The PSOEJ model is specifically for open surgery and is a portfolio expansion to the existing POWERSEAL family (K231327, K212643). The existing and proposed POWERSEAL devices share a similar handle interface designed to enhance usability and improve the surgeon's ergonomic experience.

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The Microwave Ablation Device is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation Device is not intended for cardiac use.

The Microwave Ablation Device is intended to be used together with disposable microwave ablation antenna and disposable temperature probe for soft tissue ablation. The Microwave Ablation Device consists of a generator, a disposable temperature probe and a foot switch. The Microwave Ablation Device also contains software that controls and delivers the microwave energy at a working frequency of 2450 MHz.

Principles of Operation
When being used with the disposable microwave ablation antenna, the Microwave Ablation Device generates and delivers microwave energy to the disposable microwave ablation antenna after inserting the disposable microwave ablation antenna into the diseased tissue. The microwave acts on the tissue through the disposable microwave ablation antenna, causing charged ions and water molecules in the diseased tissue to oscillate and generate intense heat (similar to a small magnetic needle rotating in a magnetic field). The localized tissue heats up, creating a temperature gradient that decreases from the center outward. When the temperature reaches above 45°C, the proteins within the cells undergo coagulative necrosis, resulting in the destruction of the diseased tissue.

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The Disposable Microwave Ablation Antenna, used in conjunction with the compatible Microwave Ablation Device, is intended for the coagulation (ablation) of soft tissue. The Disposable Microwave Ablation Antenna is not intended for cardiac use.

The Disposable Microwave Ablation Antenna is intended to be used together with Microwave Ablation Device (K252632) for soft tissue ablation. The Disposable Microwave Ablation Antenna consists of antenna, antenna shaft (temperature measurement component and cooling component), handle and coaxial cable.

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