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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Rf Innovations, Inc.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) 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. The listed applicant is Rf Innovations, Inc.. The 510(k) number is K220122.

When did APEX 6 receive FDA 510(k) clearance?

APEX 6 received FDA 510(k) clearance on 2023-03-15, under 510(k) number K220122.

Who is the listed applicant for APEX 6?

The FDA 510(k) record lists Rf Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APEX 6?

The FDA product code for APEX 6 is GXD.

Related Devices (Code: GXD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed InternationalK231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICALK201610IonicRF GeneratorABBOTT MEDICAL

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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