APEX 6— 510(k) K220122

Name: FDA 510(k) clearance K220122
Creator: U.S. Food and Drug Administration
Published: 2023-03-15

Substantially Equivalent

Rf Innovations, Inc.

FDA 510(k) clearance K220122 for APEX 6, Substantially Equivalent on 2023-03-15. Applicant: Rf Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Rf Innovations, Inc.
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 2022-01-18
Decision date: 2023-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXD

view all

K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more2025-08-07
K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)2024-08-14
K232632 — Racz Neurostat RF Generator2024-05-24
K231675 — OneRF Ablation System2023-12-06
K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS2022-01-21

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.