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The SP Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.

The SP Electrocautery Device is a single-use, disposable, battery-powered electrocautery instrument used to achieve hemostasis through coagulation of soft tissue in liver, kidney, and lung following percutaneous biopsy. The device consists of an ergonomic handpiece containing two AA alkaline batteries and control electronics connected to a stainless-steel probe shaft with a heated distal segment. When activated, electrical current heats a resistive element near the distal tip, and a thermistor provides feedback to a closed-loop controller to maintain a target operating temperature range of approximately 75-100 °C while the clinician advances or withdraws the probe within the biopsy tract.

The Single Pass device family includes multiple probe configurations that share the same handle, electronics, power source, temperature control algorithm, and patient-contact materials. This Special 510(k) introduces a new 20-gauge (GA) shaft configuration (SP20) designed for use through smaller-diameter biopsy tracts. SP20 uses the same internal heater and thermistor design and operates over the same controlled temperature range as the existing configurations. The only physical differences are a reduced shaft outer diameter (20 GA) and a minor distal tip redesign in which the shaft is sealed at the distal end without a separate end cap. Sterilization method (EtO), packaging configuration, labeled shelf life, indications for use, and intended users remain unchanged.

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The Sutter Sutter CURIS® II RF Generator is intended for:

Orthopedic, arthroscopic, spinal and neurosurgical:
For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures.

For soft tissue resection and coagulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, blepharoplasty.

Blended Cutting and Coagulation:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps.

Hemostasis and nonablative Coagulation:
Control of bleeding, epilation, teleangiectasia.

Bipolar:
Pinpoint, precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Sutter CURIS® II RF Generator is a compact source of high radiofrequency ("RF") energy to be employed for a variety of electrosurgical procedures. This is achieved by the selection of different waveforms and power levels on the front panel of the device. All selections are activated through pushbuttons and knobs. Lamps give the operator feedback on the status.

The power level for each mode is indicated by the front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch.

Monopolar and bipolar electrodes and instruments from Sutter Medizintechnik GmbH or other manufacturers are available for use.

The maximum power output of the device in CUT mode is 120 Watt at 700 Ohm load, and 80 Watt maximum in COAG mode at 60 Ohm. Operating frequency of the device is maintained at 4.0 MHz.

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The Dermatrix Duo is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The SFR applicator is indicated for:

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

The Dermatrix Duo system includes the system main body, a footswitch and two handpieces, the Microneedle RF (MFR) and the Superficial RF (SFR). The MFR handpiece is a microneedling handpiece that has 2 different configurations of cartridges: a 16 needle and a 49 needle. The SFR handpiece has 1 configuration consisting of 64 non-invasive tips. The control panel is equipped with an LCD touch screen so that users may easily adjust parameters for optimal settings. The software provides device and clinical information to the users.

The MFR handpiece creates heat within the target dermal tissue via micro needles inserted into the tissue. The microneedle cartridges are sterilized using ethylene oxide.

Using the SFR handpiece, the Dermatrix Duo system creates heat within the target dermal tissue via a matrix of electrodes on the SFR tip. There is only one type of handpiece tip (8x8 RF electrodes) that is non-sterile.

RF energy is delivered to the target tissue using the handpiece, the tip of the handpiece being placed in light contact with the epidermis, and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electrothermal reaction which is capable of achieving controlled coagulation of the target tissue.

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The ZenTite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The ZenTite is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

The ZenTite system consists of a host, a footswitch, a power cord, handpieces (optional) and electrodes (optional). The treatment handle includes a handpiece, a sterilized or not sterilized electrode. There are three types of handpieces and each type is connected with one selected electrode. They are MicroRF handpiece connected with MicroRF series electrodes (MicroRF 49, MicroRF 25, MicroRF 9N, MicroRF 25N), Artist handpiece connected with Artist series electrodes (Artist D2.0, Artist D3.5, Artist D4.5, Artist D6.0) and Pure+ handpiece connected with Pure+ B1 electrode.

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The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures

The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes.

The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode.

a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates.
b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

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The Ignite RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

Morpheus8: At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Burst and Burst Deep Applicator is limited to Skin Types I-IV.

The Ignite RF System is a computerized system generating RF energy for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis.

The Ignite RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpieces are connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available. The System is compatible with the following handpieces:

• Monopolar ("RFAL") handpieces: These handpieces are comprised of a disposable, single use plastic handle with active internal electrodes and external (return) electrodes. Both internal and external temperature are constantly monitored.

• Bipolar ("Quantum") handpieces: comprised of a disposable, single use plastic handle with active internal bipolar electrodes and no external electrodes. Control of the thermal effect is by selection of delivered amount of energy.

• Morpheus8 Burst/Burst Deep handpieces: the Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use tip head accessories. Control of the thermal effect is by selection of delivered amount of energy.

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The Irreversible Electroporation (IRE) System Generator is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.

The ENTire IRE System includes a reusable electrosurgical generator activated by a foot pedal and single-use handpieces which are provided sterile. The ENTire IRE System utilizes irreversible electroporation ("IRE"), a nonthermal ablation technology that delivers high-voltage, low-energy electrical pulses to tissue via bipolar electrodes. The system generates irreversible nanopores in the cell membranes, altering the cell membrane characteristics, and inducing apoptosis. The dead cells are then resorbed leading to tissue reduction.

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