510(k) Report

Devices descending from K063308

4 later devices reach Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070496Advacoat Sinus Gel and StentCarbylan Biosurgery20073—
+2K160101SinuBandBioinspire Technologies, Incorporated20160—
+2K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc.20091—
+3K170913Composite Removable Sinus Stent SystemSts Medical20170—