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Entellus Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K220027Audion ET dilation systemApril 12, 2022
K163509XprESS ENT Dilation SystemApril 5, 2017
K163435Entellus Medical Reinforced Anesthesia NeedleApril 5, 2017
K152434XprESS Multi-Sinus Dilation SystemNovember 20, 2015
K152435PassAssist LED Light FiberNovember 20, 2015
K142252XprESS Multi-Sinus Dilation ToolOctober 17, 2014
K141916PATHASSIST LED LIGHT FIBERAugust 7, 2014
K133563PATHASSIST LIGHT SEEKERDecember 20, 2013
K132440XPRESS MULTI-SINUS DILATION TOOLOctober 4, 2013
K130503PATHASSIST LED LIGHT FIBERJune 11, 2013
K121943XPRESS MULTI-SINUS DILATION TOOLAugust 22, 2012
K121174XPRESS MULTI-SINUS DILATION TOOLMay 17, 2012
K120962PATHASSIST LIGHT FIBERApril 27, 2012
K120735PATHASSIT LIGHT SEEKERApril 2, 2012
K113522PATHASSIST LIGHT SEEKERJanuary 27, 2012
K112506XPRESS MULTI-SINUS DILATION TOOLDecember 21, 2011
K111763PATHASSIST LIGHT FIBERSeptember 15, 2011
K110739ENTELLUS MEDICAL SINUS GUIDEWIREJune 14, 2011
K110158ILLUMINATING SINUS SEEKERJune 7, 2011
K102366FINESS ENDOSCOPEFebruary 15, 2011