K252083

HOTWIRE System RF Generator and Footswitch (optional accessory)

510(k) number: K252083
Device name: HOTWIRE System RF Generator and Footswitch (optional accessory)
Applicant: Atraverse Medical, Inc. CA · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2025-08-12
Date received: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Flag: Third-party review
Advisory committee: General, Plastic Surgery

Also available from FDA: K252083.pdf

Official FDA record: K252083

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.