510(k) Report

Devices descending from K951066

4 later devices reach Rains Frontal Sinus Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072891Sinus SpacerAcclarent, Inc.20083—
+2K083574Relieva Stratus Microflow SpacerAcclarent, Inc.20092—
+3K093594Modification to Relieva Stratus Microflow SpacerAcclarent, Inc.20101—
+4K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc.20110—