FDA.reportPublic FDA data

HOTWIRE™ System RF Generator

Primary DI
00850057445251
Brand
HOTWIRE™ System RF Generator
Company
Atraverse Medical, Inc
Model
903001
Catalog number
HB1
Device description
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.
Published
2025-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252083000HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc.2025-08-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057445251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057445251008500574452518500574452510850057445251

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.6Inch
Length10.1Inch
Width4.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 millibar1060 millibar
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118954537
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057445275HOTWIRE™ RF GUIDEWIRE902002H2J-032-180-ABT-02025-10-01
00850057445282HOTWIRE™ RF GUIDEWIRE902003H2P-032-180-ABT-02025-10-01
00850057445299HOTWIRE™ RF GUIDEWIRE902004H2S-032-230-ABT-02025-10-01
00850057445305HOTWIRE™ RF GUIDEWIRE902005H2J-032-230-ABT-02025-10-01
00850057445312HOTWIRE™ RF GUIDEWIRE902006H2P-032-230-ABT-02025-10-01
00850057445329HOTWIRE™ RF GUIDEWIRE902007H2S-032-180-BWI-02025-10-01
00850057445336HOTWIRE™ RF GUIDEWIRE902008H2J-032-180-BWI-02025-10-01
00850057445343HOTWIRE™ RF GUIDEWIRE902009H2P-032-180-BWI-02025-10-01
00850057445350HOTWIRE™ RF GUIDEWIRE902010H2S-032-230-BWI-02025-10-01
00850057445367HOTWIRE™ RF GUIDEWIRE902011H2J-032-230-BWI-02025-10-01
00850057445374HOTWIRE™ RF GUIDEWIRE902012H2P-032-230-BWI-02025-10-01
00850057445381HOTWIRE™ RF GUIDEWIRE902013H2S-035-180-MDT-02025-10-01
00850057445398HOTWIRE™ RF GUIDEWIRE902014H2J-035-180-MDT-02025-10-01
00850057445404HOTWIRE™ RF GUIDEWIRE902015H2P-035-180-MDT-02025-10-02
00850057445411HOTWIRE™ RF GUIDEWIRE902016H2S-035-230-MDT-02025-10-02
00850057445428HOTWIRE™ RF GUIDEWIRE902017H2J-035-230-MDT-02025-10-02
00850057445435HOTWIRE™ RF GUIDEWIRE902018H2P-035-230-MDT-02025-10-02
00850057445442HOTWIRE™ RF GUIDEWIRE902019H2S-035-180-LAA-02025-10-02
00850057445459HOTWIRE™ RF GUIDEWIRE902020H2J-035-180-LAA-02025-10-02
00850057445466HOTWIRE™ RF GUIDEWIRE902021H2P-035-180-LAA-02025-10-02

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Primary DI, Brand, Company table
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08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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