HOTWIRE™ System RF Generator HB1

GUDID 00850057445251

The HOTWIRE™ System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF puncture devices which are connected to the RF Generator through a HOTWIRE™ System Handpiece. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available neutral electrode, such as the Valleylab Model #E7507 (K822572). An optional HOTWIRE™ System Footswitch may be used with the RF Generator. Refer to Table 1 for the Model Numbers of the HOTWIRE™ System RF Generator and accessory devices covered by this application.

Atraverse Medical, Inc

Electrosurgical system generator

• Primary Device ID: 00850057445251
• NIH Device Record Key: 572e14f2-050f-48e7-bbb6-0db4c152601c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOTWIRE™ System RF Generator
• Version Model Number: 903001
• Catalog Number: HB1
• Company DUNS: 118954537
• Company Name: Atraverse Medical, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch
• Height: 4.6 Inch
• Length: 10.1 Inch
• Width: 4.5 Inch

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057445251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252083

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-17
• Device Publish Date: 2025-09-09

Devices Manufactured by Atraverse Medical, Inc

• 00850057445268 - HOTWIRE™ RF GUIDEWIRE: 2025-10-06 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445251 - HOTWIRE™ System RF Generator: 2025-09-17The HOTWIRE™ System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF puncture devices which are connected to the RF Generator through a HOTWIRE™ System Handpiece. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available neutral electrode, such as the Valleylab Model #E7507 (K822572). An optional HOTWIRE™ System Footswitch may be used with the RF Generator. Refer to Table 1 for the Model Numbers of the HOTWIRE™ System RF Generator and accessory devices covered by this application.
• 00850057445251 - HOTWIRE™ System RF Generator: 2025-09-17 The HOTWIRE™ System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF puncture dev
• 00850057445626 - HOTWIRE™ System Footswitch: 2025-09-17
• 00850057445008 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445015 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445022 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445039 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445046 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal