FDA.reportPublic FDA data

Entellus Medical, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063458723006345872Entellus Medical, Inc1N2026-01-013600 Holly Lane North, Suite 40 Plymouth MN US 55447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2247561665168098K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
2247561797350066K193502TGS Universal Headrest with Mounting ArmPGW2020-02-14
2247561700583036K193118TGS Guidewire and updated Scopis SoftwarePGW2020-02-21
2247561368656052K192661LATERA Absorbable Nasal Implant SystemNHB2019-11-10
2247561861662661K163509XprESS ENT Dilation SystemPNZ2017-04-05
2247561619868673K163435Entellus Medical Reinforced Anesthesia NeedleBSP2017-04-05
2247562008017237K161191Latera Absorbable Nasal ImplantNHB2016-06-23
2247561615959581K152958INEX Absorbable Nasal ImplantNHB2015-12-04
2247561067997162K152435PassAssist LED Light FiberLRC2015-11-20
2247561987072691K152434XprESS Multi-Sinus Dilation SystemLRC2015-11-20
2247561719758922K142252XprESS Multi-Sinus Dilation ToolLRC2014-10-17
2247561274419742K133563PATHASSIST LIGHT SEEKERLRC2013-12-20
2247561569315793K113585NASAL/EPISTAXIS PACKLYA2012-04-25
2247561361005219
2247561646301590
2247561017176448
2247561038371666
2247561203444525
2247561223036166
2247561678962605
2247561993276853

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHB42019-11-10
LRC42015-11-20
PGW22020-02-21
BSP12017-04-05
PNZ12017-04-05
LYA12012-04-25
EOB11998-08-13