510(k) Report

Devices descending from K240171

3 later devices reach ProSeal™ Injector Plus (Model no. 421050) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte., Ltd.20250—
+1K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte., Ltd.20240—
+1K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte., Ltd.20240—