K243652
- 510(k) number
- K243652
- Device name
- Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
- Applicant
- Cardinalhealth IL · US
- Product code
- PNR — Enteral Syringes With Enteral Specific Connectors
- Decision date
- 2024-12-19
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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: K243652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.