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FDA 510(k)

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR

K-Number: K901540 · 1991-04-08

ApplicantRadionics, Inc.
Decision Date1991-04-08
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1991-04-08 under 510(k) number K901540. 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 MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR?

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Radionics, Inc.. The 510(k) number is K901540.

When did MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR receive FDA 510(k) clearance?

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR received FDA 510(k) clearance on 1991-04-08, under 510(k) number K901540.

Who is the listed applicant for MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR?

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

What is the FDA product code for MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR?

The FDA product code for MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR is GXD.

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Other records listing Radionics, Inc. as applicant

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.

K030697RADIONICS SINGLE USE GROUND PAD (DGP-HP)K002773NEUROMAP WITH NEURO 100K001741RADIONICS RF DISC CATHETER ELECTRODE SYSTEMK992226XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMK001950OPTICAL TRACKING SYSTEM (OTS)K001700XPLAN 2.1

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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.K220122APEX 6Rf Innovations, 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.

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