Entellus Medical, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K220027	Audion ET dilation system	PNZ	2022-04-12	View
510(k)	K163509	XprESS ENT Dilation System	PNZ	2017-04-05	View
510(k)	K163435	Entellus Medical Reinforced Anesthesia Needle	BSP	2017-04-05	View
510(k)	K133563	PATHASSIST LIGHT SEEKER	LRC	2013-12-20	View
510(k)	K132440	XPRESS MULTI-SINUS DILATION TOOL	LRC	2013-10-04	View
510(k)	K130503	PATHASSIST LED LIGHT FIBER	LRC	2013-06-11	View
510(k)	K121943	XPRESS MULTI-SINUS DILATION TOOL	LRC	2012-08-22	View
510(k)	K121174	XPRESS MULTI-SINUS DILATION TOOL	LRC	2012-05-17	View
510(k)	K120962	PATHASSIST LIGHT FIBER	LRC	2012-04-27	View
510(k)	K120735	PATHASSIT LIGHT SEEKER	LRC	2012-04-02	View
510(k)	K113522	PATHASSIST LIGHT SEEKER	LRC	2012-01-27	View
510(k)	K112506	XPRESS MULTI-SINUS DILATION TOOL	LRC	2011-12-21	View
510(k)	K111763	PATHASSIST LIGHT FIBER	LRC	2011-09-15	View
510(k)	K110739	ENTELLUS MEDICAL SINUS GUIDEWIRE	LRC	2011-06-14	View
510(k)	K110158	ILLUMINATING SINUS SEEKER	LRC	2011-06-07	View
510(k)	K102366	FINESS ENDOSCOPE	EOB	2011-02-15	View
510(k)	K103213	FINESS ENDOSCOPE STERILIZATION TRAY	KCT	2011-02-02	View
510(k)	K102003	XPRESS BALLOON DEVICE	LRC	2010-10-22	View
510(k)	K093007	ENTELLUS MEDICAL BALLOON DEVICE	LRC	2010-02-05	View
510(k)	K091681	FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)	LRC	2009-07-08	View