Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

46 results for "Acclarent, Inc."
25–46 of 46
Search insights Median review: 103d Cleared: 98% Top manufacturer: Acclarent, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 280d
Cleared Oct 11, 2011
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 102d
Cleared Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
K110687 · KAM
Acclarent, Inc.
General & Plastic Surgery · 210d
Cleared Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K111254 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 110d
Cleared Jun 16, 2011
TULA IONTOPHORESIS SYSTEM
K110636 · EGJ
Acclarent, Inc.
Physical Medicine · 104d
Cleared May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 134d
Cleared CT Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 114d
Cleared Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 65d
Cleared Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 311d
Cleared Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
K093594 · KAM
Acclarent, Inc.
General & Plastic Surgery · 104d
Cleared Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 92d
Cleared Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
K083574 · KAM
Acclarent, Inc.
General & Plastic Surgery · 57d
Cleared Sep 19, 2008
TYMPANOSTOMY TUBE
K082188 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 19, 2008
SINUS SPACER
K072891 · KAM
Acclarent, Inc.
General & Plastic Surgery · 161d
Cleared Mar 11, 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
K073041 · KAM
Acclarent, Inc.
General & Plastic Surgery · 134d
Cleared Mar 05, 2008
IONTOPHORESIS SYSTEM
K073276 · EGJ
Acclarent, Inc.
Physical Medicine · 105d
Cleared Sep 28, 2007
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
K071845 · KAM
Acclarent, Inc.
General & Plastic Surgery · 85d
Cleared Oct 24, 2006
MICROENDOSCOPE
K063078 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 15, 2006
ETHMOID SINUS SPACER
K062458 · KAM
Acclarent, Inc.
General & Plastic Surgery · 23d
Cleared Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
K061903 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 44d
Cleared May 05, 2006
RELIENT NAVIGATION DEVICE
K060974 · KAM
Acclarent, Inc.
General & Plastic Surgery · 25d
Cleared Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
K052198 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 19d