FDA 510(k)

HOTWIRE System RF Generator and Footswitch (optional accessory)

K-Number: K252083 · 2025-08-12

Decision Date2025-08-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HOTWIRE System RF Generator and Footswitch (optional accessory) is a medical device manufactured by Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-12 under approval number K252083. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTWIRE System RF Generator and Footswitch (optional accessory)?

HOTWIRE System RF Generator and Footswitch (optional accessory) is a medical device that received FDA 510(k) clearance on 2025-08-12. It is manufactured by Atraverse Medical, Inc.. The 510(k) number is K252083.

When was HOTWIRE System RF Generator and Footswitch (optional accessory) approved by the FDA?

HOTWIRE System RF Generator and Footswitch (optional accessory) received FDA 510(k) clearance on 2025-08-12, under approval number K252083.

What company makes HOTWIRE System RF Generator and Footswitch (optional accessory)?

HOTWIRE System RF Generator and Footswitch (optional accessory) is manufactured by Atraverse Medical, Inc..

What is the FDA product code for HOTWIRE System RF Generator and Footswitch (optional accessory)?

The FDA product code for HOTWIRE System RF Generator and Footswitch (optional accessory) is GEI.

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Other Devices by Atraverse Medical, Inc.

K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.