K240965
- 510(k) number
- K240965
- Device name
- CORTRAK* 2 Enteral Access System (20-0950)
- Applicant
- Avanos Medical, Inc. GA · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2024-06-06
- Date received
- 2024-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.