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FDA 510(k)

HOTWIRE™ System RF Generator and Footswitch (optional accessory)

K-Number: K252083 · 2025-08-12

ApplicantAtraverse Medical, Inc.
Decision Date2025-08-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOTWIRE™ System RF Generator and Footswitch (optional accessory) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) 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. The listed applicant is Atraverse Medical, Inc.. The 510(k) number is K252083.

When did HOTWIRE™ System RF Generator and Footswitch (optional accessory) receive FDA 510(k) clearance?

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

Who is the listed applicant for HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

The FDA 510(k) record lists Atraverse Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Atraverse Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)K240900HOTWIRE™ RF Guidewire

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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