510(k) Report

Devices descending from K192075

4 later devices reach ProSeal™ Closed System drug Transfer Device (CSTD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240171ProSeal™ Injector Plus (Model no. 421050)Epic Medical Pte., Ltd.20243—
+2K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte., Ltd.20250—
+2K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte., Ltd.20240—
+2K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte., Ltd.20240—