HOTWIRE™ System RF Generator

FDA UDI

Class II (US FDA UDI)

by Atraverse Medical

Identity

Trade Name: HOTWIRE™ System RF Generator FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 903001 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: HB1 FDA UDI
Primary DI / UDI-DI: 00850057445251 FDA UDI
510(k) Number: K252083 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 4.6 Inch FDA UDI
Length — 10.1 Inch FDA UDI
Width — 4.5 Inch FDA UDI

Category: Electrosurgical system generator

HOTWIRE™ System RF Generator by Atraverse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system generator.

Cook — COOK INCORPORATED · Class II
LEEP PRECISION™ Generator — CooperSurgical, Inc. · Class II
AEXTM — MEDTRONIC, INC. · Class II
Cook — COOK INCORPORATED · Class II
Endovapor® — JOIMAX, INC. · Class II
WEREWOLF — Smith & Nephew, Inc. · Class II
PerFect TCS — Coltene/Whaledent Inc. · Class II
INTELLIO SHIFT — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K252083 also covers:

HOTWIRE™ System Footswitch — Atraverse Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Atraverse Medical

Sources (1)

FDA UDI 572e14f2-050f-48e7-bbb6-0db4c152601c 37 fields · synced May 30, 2026