HOTWIRE™ System Footswitch

FDA UDI

Class II (US FDA UDI)

by Atraverse Medical

Identity

Trade Name: HOTWIRE™ System Footswitch FDA UDI
Generic Name: Foot-switch, electrical FDA UDI
Model / Reference: 905001 FDA UDI

Identifiers

Catalog Number: FS1 FDA UDI
Primary DI / UDI-DI: 00850057445626 FDA UDI
510(k) Number: K252083 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Foot-switch, electrical 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Foot-switch, electrical

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

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Cleared under the same submission

K252083 also covers:

HOTWIRE™ System RF Generator — 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 29870d00-1558-4d71-8a91-6fa1b9711b20 35 fields · synced May 30, 2026