K243228
- 510(k) number
- K243228
- Device name
- Flexi-Seal AIR (with ENFit Connector)
- Applicant
- Convatec GB
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2025-03-28
- Date received
- 2024-10-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243228.pdf
Official FDA record: K243228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.