Home / 510(k) Clearances / K242057

510(k) K242057

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) by Avanos Medical, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
July 15, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Avanos Medical, Inc.

  • K243572 — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready (January 31, 2025)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS) (April 22, 2022)
  • K203066 — COOLIEF Cooled Radiofrequency Kit Advanced (December 22, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K191340 — CORTRAK* 2 Equilateral Enteral Access System (June 4, 2019)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K181864 — Polaris RF Ablation System (January 2, 2019)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)
  • K170242 — MultiGen™ 2 RF Generator System (May 25, 2017)