LRC · Class I · 21 CFR 874.4420

FDA Product Code LRC: Instrument, Ent Manual Surgical

Leading manufacturers include Entellus Medical, Inc., Acclarent, Inc. and Exmoor Plastics , Ltd..

65
Total
65
Cleared
102d
Avg days
1987
Since
65 devices
25–48 of 65
Cleared Dec 09, 2013
VENT-OS SINUS DILATION SYSTEM
K133016
Sinusys Corporation
Ear, Nose, Throat · 75d
Cleared Nov 05, 2013
EM SINUS DILATION SYSTEM
K132297
Medtronic Xomed, Inc.
Ear, Nose, Throat · 104d
Cleared Oct 04, 2013
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709
Arthrocare Corp.
Ear, Nose, Throat · 115d
Cleared Oct 04, 2013
XPRESS MULTI-SINUS DILATION TOOL
K132440
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Jun 11, 2013
PATHASSIST LED LIGHT FIBER
K130503
Entellus Medical, Inc.
Ear, Nose, Throat · 104d
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280
Acclarent, Inc.
Ear, Nose, Throat · 280d
Cleared Aug 29, 2012
SINUS DILATION SYSTEM
K121351
Entrigue Surgical, Inc.
Ear, Nose, Throat · 117d
Cleared Aug 22, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943
Entellus Medical, Inc.
Ear, Nose, Throat · 50d
Cleared May 17, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121174
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 27, 2012
PATHASSIST LIGHT FIBER
K120962
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 02, 2012
PATHASSIT LIGHT SEEKER
K120735
Entellus Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 27, 2012
PATHASSIST LIGHT SEEKER
K113522
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 21, 2011
XPRESS MULTI-SINUS DILATION TOOL
K112506
Entellus Medical, Inc.
Ear, Nose, Throat · 113d
Cleared Oct 11, 2011
RELIEVA SPIN SINUS DILATION SYSTEM
K111875
Acclarent, Inc.
Ear, Nose, Throat · 102d
Cleared Sep 15, 2011
PATHASSIST LIGHT FIBER
K111763
Entellus Medical, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K111254
Acclarent, Inc.
Ear, Nose, Throat · 110d
Cleared Jun 14, 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739
Entellus Medical, Inc.
Ear, Nose, Throat · 89d
Cleared Jun 07, 2011
ILLUMINATING SINUS SEEKER
K110158
Entellus Medical, Inc.
Ear, Nose, Throat · 139d
Cleared Oct 22, 2010
XPRESS BALLOON DEVICE
K102003
Entellus Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Feb 05, 2010
ENTELLUS MEDICAL BALLOON DEVICE
K093007
Entellus Medical, Inc.
Ear, Nose, Throat · 130d
Cleared Jul 08, 2009
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 27, 2008
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542
Entellus Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Apr 08, 2008
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302
Entellus Medical, Inc.
Ear, Nose, Throat · 235d
Cleared Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
K061903
Acclarent, Inc.
Ear, Nose, Throat · 44d