510(k) Report

Devices descending from K241988

2 later devices reach ProSeal™ Closed System Bag Access through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+1K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—