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Monoject™ Enteral Syringe with ENFit Connector (401SE) +5 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243652

by Cardinalhealth

Identifiers

510(k) Number
K243652 FDA 510(k)
FDA Product Code
PNR FDA 510(k)
Models / Variants
Monoject™ Enteral Syringe with ENFit Connector (401SE) FDA 510(k)
Monoject™ Enteral Syringe with ENFit Connector (403SE) FDA 510(k)
Monoject™ Enteral Syringe with ENFit Connector (406SE) FDA 510(k)
Monoject™ Enteral Syringe with ENFit Connector (412SE) FDA 510(k)
Monoject™ Enteral Syringe with ENFit Connector (435SE) FDA 510(k)
Monoject™ Enteral Syringe with ENFit Connector (460SE) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Monoject™ Enteral Syringe with ENFit Connector (401SE) +5 more models by Cardinalhealth — Class II — FDA_510K — listed in FDA 510(k) — 6 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA 510(k) K243652 24 fields · synced Jun 18, 2026