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FDA 510(k)

Coolief Radiofrequency Generator (CRG) System

K-Number: K192491 · 2020-02-21

ApplicantAvanos Medical, Inc.
Decision Date2020-02-21
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Coolief Radiofrequency Generator (CRG) System is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K192491. 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 Coolief Radiofrequency Generator (CRG) System?

Coolief Radiofrequency Generator (CRG) System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K192491.

When did Coolief Radiofrequency Generator (CRG) System receive FDA 510(k) clearance?

Coolief Radiofrequency Generator (CRG) System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192491.

Who is the listed applicant for Coolief Radiofrequency Generator (CRG) System?

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

What is the FDA product code for Coolief Radiofrequency Generator (CRG) System?

The FDA product code for Coolief Radiofrequency Generator (CRG) System is GXD.

Other records listing Avanos Medical, Inc. as applicant

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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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