510(k) Report

Devices descending from DEN150010

6 later devices reach Dignitana AB DigniCap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170871DigniCap Scalp Cooling SystemDignitana AB20172—
+1K163484Paxman Scalp CoolerPaxman Coolers Limited20172—
+2K191166DigniCap DeltaDignitana, Inc.201911
+2K173032Paxman Scalp CoolerPaxman Coolers Limited20181—
+3K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited20250—
+3K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.20210—