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510(k) K220122

APEX 6 by Rf Innovations, Inc. — Product Code GXD

K220122 is an FDA 510(k) premarket notification submitted by Rf Innovations, Inc. for the device "APEX 6". The FDA issued a decision of Substantially Equivalent on March 15, 2023. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2023
Date Received
January 18, 2022
Clearance Type
Traditional
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

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  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 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)

FDA data resources