510(k) Report

Devices descending from K070496

3 later devices reach Advacoat Sinus Gel and Stent through their predicates, nearest generation first.

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