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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 a medical device manufactured by Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under approval 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. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K192491.

When was Coolief Radiofrequency Generator (CRG) System approved by the FDA?

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

What company makes Coolief Radiofrequency Generator (CRG) System?

Coolief Radiofrequency Generator (CRG) System is manufactured by Avanos Medical, Inc..

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

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

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Other Devices by Avanos Medical, Inc.

K191340CORTRAK* 2 Equilateral Enteral Access System K203066COOLIEF Cooled Radiofrequency Kit Advanced K220588Avanos* CORTRAK* 2 Enteral Access System (EAS) K241185CORGRIP* SR NG/NI Tube Retention System K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) K240965CORTRAK* 2 Enteral Access System (20-0950)

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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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