510(k) Report

Devices descending from K183236

3 later devices reach Rotium Bioresorbable Wick through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241912BiochargeNanofiber Solutions, LLC20240—
+1K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+1K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—