Acclarent, Inc. - FDA 510(k) Cleared Devices
45
Total
44
Cleared
1
Denied
45 devices
Cleared
Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
General & Plastic Surgery
210d
Cleared
Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
Ear, Nose, Throat
110d
Cleared
Jun 16, 2011
TULA IONTOPHORESIS SYSTEM
Physical Medicine
104d
Cleared
May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Ear, Nose, Throat
134d
Cleared
Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
Ear, Nose, Throat
114d
Cleared
Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
Ear, Nose, Throat
65d
Cleared
Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Ear, Nose, Throat
311d
Cleared
Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
General & Plastic Surgery
104d
Cleared
Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
Ear, Nose, Throat
92d
Cleared
Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
General & Plastic Surgery
57d
Cleared
Sep 19, 2008
TYMPANOSTOMY TUBE
Ear, Nose, Throat
46d
Cleared
Mar 19, 2008
SINUS SPACER
General & Plastic Surgery
161d
Cleared
Mar 11, 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
General & Plastic Surgery
134d
Cleared
Mar 05, 2008
IONTOPHORESIS SYSTEM
Physical Medicine
105d
Cleared
Sep 28, 2007
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
General & Plastic Surgery
85d
Cleared
Oct 24, 2006
MICROENDOSCOPE
Ear, Nose, Throat
14d
Cleared
Sep 15, 2006
ETHMOID SINUS SPACER
General & Plastic Surgery
23d
Cleared
Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
Ear, Nose, Throat
44d
Cleared
May 05, 2006
RELIENT NAVIGATION DEVICE
General & Plastic Surgery
25d
Cleared
Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
Ear, Nose, Throat
19d