HOTWIRE System RF Generator and Footswitch (optional accessory)— 510(k) K252083

Substantially Equivalent

Atraverse Medical, Inc.

FDA 510(k) clearance K252083 for HOTWIRE System RF Generator and Footswitch (optional accessory), Substantially Equivalent on 2025-08-12. Applicant: Atraverse Medical, Inc..

Clearance details

Applicant: Atraverse Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-07-02
Decision date: 2025-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cardiff By The Sea, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.