COOLIEF Cooled Radiofrequency Kit Advanced— 510(k) K203066
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K203066 for COOLIEF Cooled Radiofrequency Kit Advanced, Substantially Equivalent on 2020-12-22. Applicant: Avanos Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avanos Medical, Inc.
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code GXI
view allMore clearances from Avanos Medical, Inc.
view all- K243572 — Game Ready system (550500-04) +11 more
- K241185 — CORGRIP* SR NG/NI Tube Retention System
- K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- K240965 — CORTRAK* 2 Enteral Access System (20-0950)
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.