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FDA 510(k)

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

K-Number: K242057 · 2024-08-14

ApplicantAvanos Medical, Inc.
Decision Date2024-08-14
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) is a medical device manufactured by Avanos Medical, Inc.. It received FDA 510(k) clearance on 2024-08-14 under approval number K242057. 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-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)?

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) is a medical device that received FDA 510(k) clearance on 2024-08-14. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K242057.

When was COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) approved by the FDA?

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) received FDA 510(k) clearance on 2024-08-14, under approval number K242057.

What company makes COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)?

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) is manufactured by Avanos Medical, Inc..

What is the FDA product code for COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)?

The FDA product code for COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) is GXD.

Other Devices by Avanos Medical, Inc.

K191340CORTRAK* 2 Equilateral Enteral Access System K203066COOLIEF Cooled Radiofrequency Kit Advanced K192491Coolief Radiofrequency Generator (CRG) System K220588Avanos* CORTRAK* 2 Enteral Access System (EAS) K241185CORGRIP* SR NG/NI Tube Retention System K240965CORTRAK* 2 Enteral Access System (20-0950)

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Related Devices (Code: GXD)

K171143Relievant Medsystems RF GeneratorRelievant Medsystems K170242MultiGen™ 2 RF Generator SystemStryker Corporation K181864Polaris RF Ablation SystemBaylis Medical Company, Inc. K201610IonicRF GeneratorABBOTT MEDICAL K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, 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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