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

Name: FDA 510(k) clearance K252083
Creator: U.S. Food and Drug Administration
Published: 2025-08-12

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.. Device class: 2.

Clearance details

Applicant: Atraverse Medical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
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 ↗

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K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Atraverse Medical, Inc.

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K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)2025-08-27

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.