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
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17