APEX 6
K-Number: K220122 · 2023-03-15
ApplicantRf Innovations, Inc.
Decision Date2023-03-15
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
APEX 6 is a medical device manufactured by Rf Innovations, Inc.. It received FDA 510(k) clearance on 2023-03-15 under approval number K220122. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the APEX 6?
APEX 6 is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Rf Innovations, Inc.. The 510(k) number is K220122.
When was APEX 6 approved by the FDA?
APEX 6 received FDA 510(k) clearance on 2023-03-15, under approval number K220122.
What company makes APEX 6?
APEX 6 is manufactured by Rf Innovations, Inc..
What is the FDA product code for APEX 6?
The FDA product code for APEX 6 is GXD.
Related Devices (Code: GXD)
K171143Relievant Medsystems RF GeneratorRelievant Medsystems
K170242MultiGen 2 RF Generator SystemStryker Corporation
K181864Polaris RF Ablation SystemBaylis Medical Company, Inc.
K201610IonicRF GeneratorABBOTT MEDICAL
K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc.
K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICAL
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.