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)— 510(k) K243652

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K243652 for 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), Substantially Equivalent on 2024-12-19. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-26
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.