Cleared Traditional

HOTWIRE? System RF Generator and Footswitch (optional accessory)

K252083 · Atraverse Medical, Inc. · General & Plastic Surgery

Aug 2025

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K252083 is an FDA 510(k) clearance for the HOTWIRE? System RF Generator and Footswitch (optional accessory), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Atraverse Medical, Inc. (Cardiff By The Sea, US). The FDA issued a Cleared decision on August 12, 2025, 41 days after receiving the submission on July 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K252083 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2025
Decision Date	August 12, 2025
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).