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510(k) K252083

HOTWIRE™ System RF Generator and Footswitch (optional accessory) by Atraverse Medical, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2025
Date Received
July 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Atraverse Medical, Inc.

  • K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (February 27, 2026)
  • K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (August 27, 2025)
  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)