Class Class II

HOTWIRE™ System RF Generator and Footswitch (optional accessory) (K252083)

K252083 2025-08-12 Traditional
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Description

HOTWIRE™ System RF Generator and Footswitch (optional accessory) by Atraverse Medical, Inc., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252083
Clearance Date2025-08-12
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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Predicate lineage for K252083

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HOTWIRE™ System RF Generator and Footswitch (optional accessory) (K252083) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K232809Cross Vascular RF Generator and Footswitch (optional access...Cross Vascular, Inc.2023
K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATORBaylis Medical Company, Inc.2012

Trace the full predicate network for K252083

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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