Coolief Radiofrequency Generator (CRG) System
FDA 510(k) K192491 · Avanos Medical, Inc.
510(k) numberK192491
Submission
- Device name
- Coolief Radiofrequency Generator (CRG) System
- Applicant
- Avanos Medical, Inc.
Alpharetta, GA, US - Received
- September 11, 2019
- Decision date
- February 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
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| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | 10/25/2024SE |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special | 08/14/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | 06/06/2024SE |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT · Traditional | 04/22/2022SE |
| K203066 | COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional | 12/22/2020SE |
| K191340 | CORTRAK* 2 Equilateral Enteral Access SystemKNT · Special | 06/04/2019SE |
Questions and answers
When was Coolief Radiofrequency Generator (CRG) System cleared by the FDA?
Coolief Radiofrequency Generator (CRG) System (K192491) received a 510(k) decision of Substantially Equivalent on February 21, 2020, 163 days after the submission was received.
What is the product code of K192491?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.