510(k) Report

Devices descending from K861389

3 later devices reach Pap Smear Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182049exCellerator Cervical Collection DeviceExcell Company, LLC20190—
+1K153128Kolplast Cervical Sample Collection KitKolplast CI SA20170—
+1K062433Diamics Cercol Cervical Sample Collector SystemDiamics, Inc.20070—