FDA.reportPublic FDA data

HOTWIRE™ System Footswitch

Primary DI
00850057445626
Brand
HOTWIRE™ System Footswitch
Company
Atraverse Medical, Inc
Model
905001
Catalog number
FS1
Published
2025-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850057445626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057445626008500574456268500574456260850057445626

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 760-278-8098info@atraversemedical.com

Regulatory Flags#

DUNS number
118954537
Device count
1
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07