510(k) Report

Devices descending from K091635

4 later devices reach Venus Diamond Flow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC20260—
+1K220605Venus Bulk Flow ONEKulzer, LLC20222—
+1K141994Bulk Fill Flowable CompositeNovocol, Inc.20140—
+2K250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…Kettenbach GmbH & Co. KG20250—