510(k) Report

Devices descending from K161045

3 later devices reach Monoject through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3…Intervene Group Limited20170—
+1K161963Monoject Enteral Syringe with ENFit ConnectorCovidien20162—
+2K161811Medela Low Dose Enteral SyringeMedela, Inc.201701