CORTRAK* 2 Enteral Access System (20-0950)— 510(k) K240965
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K240965 for CORTRAK* 2 Enteral Access System (20-0950), Substantially Equivalent on 2024-06-06. Applicant: Avanos Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avanos Medical, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code KNT
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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)
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.