Atlas FDA

LRC

65 FDA 510(k) clearances · Product code

85 daysmedian time to decision
163 days90th percentile
65clearances measured

FDA profile

Official device name
Instrument, Ent Manual Surgical
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2020: 20 · 2021: 23 · 2022: 25 · 2024: 51 · 2025: 44 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BB 8 Sinus Dilation Kit (K230258)Excelent, Inc.2023-05-25
VenSure LightGuide (K212774)Intersect Ent.2022-02-04
SINUSPRIME Dilation System (K201398)Stryker Ent2020-10-15
Next Generation Balloon Dilation System (K201115)Acclarent, Inc.2020-08-27
VenSure Balloon Device, VenSure Nav Balloon Device (K201472)Fiagon GmbH2020-08-26
Dillard Nasal Balloon Catheter (K181546)Intuit Medical Products, LLC2020-01-03
RELIEVA ULTIRRA Sinus Balloon Catheter (K190525)Acclarent, Inc.2019-05-03
Sinusway Dilation System (K181838)3nt Medical , Ltd.2018-12-20
MESIRE - Balloon Sinus Dilatation System (K172737)M/S. Meril Life Sciences Private Limited2017-12-12
Relieva SpinPlus Nav Balloon Sinuplasty System (K171687)Acclarent, Inc.2017-09-05
Relieva UltirraNav Sinus Balloon Catheter (K161698)Acclarent, Inc.2016-10-24
Vent-Os Sinus Dilation family (K160770)Sinusys Corporation2016-06-29
Relieva Scout Multi-Sinus Dilation System (K153341)Acclarent, Inc.2016-02-12
NuVent EM Sinus Dilation System (K152121)Medtronic Xomed, Inc.2015-12-01
XprESS Multi-Sinus Dilation System (K152434)Entellus Medical, Inc.2015-11-20
PassAssist LED Light Fiber (K152435)Entellus Medical, Inc.2015-11-20
DSS Sinusplasty Balloon Catheter (K143738)Intuit Medical Products, LLC2015-08-27
Relieva SpinPlus Balloon Sinuplasty System (K143541)Acclarent, Inc.2015-04-22
ACCLARENT SE Inflation Device (K150172)Acclarent, Inc.2015-04-07
XprESS Multi-Sinus Dilation Tool (K142252)Entellus Medical, Inc.2014-10-17
PATHASSIST LED LIGHT FIBER (K141916)Entellus Medical, Inc.2014-08-07
RELIEVA SCOUT SINUS DILATION SYSTEM (K140160)Acclarent, Inc.2014-02-20
PATHASSIST LIGHT SEEKER (K133563)Entellus Medical, Inc.2013-12-20
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (K130736)Helix Medical, LLC2013-12-17
VENT-OS SINUS DILATION SYSTEM (K133016)Sinusys Corporation2013-12-09
EM SINUS DILATION SYSTEM (K132297)Medtronic Xomed, Inc.2013-11-05
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (K131709)Arthrocare Corp.2013-10-04
XPRESS MULTI-SINUS DILATION TOOL (K132440)Entellus Medical, Inc.2013-10-04
PATHASSIST LED LIGHT FIBER (K130503)Entellus Medical, Inc.2013-06-11
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM (K120280)Acclarent, Inc.2012-11-05
SINUS DILATION SYSTEM (K121351)Entrigue Surgical, Inc.2012-08-29
XPRESS MULTI-SINUS DILATION TOOL (K121943)Entellus Medical, Inc.2012-08-22
XPRESS MULTI-SINUS DILATION TOOL (K121174)Entellus Medical, Inc.2012-05-17
PATHASSIST LIGHT FIBER (K120962)Entellus Medical, Inc.2012-04-27
PATHASSIT LIGHT SEEKER (K120735)Entellus Medical, Inc.2012-04-02
PATHASSIST LIGHT SEEKER (K113522)Entellus Medical, Inc.2012-01-27
XPRESS MULTI-SINUS DILATION TOOL (K112506)Entellus Medical, Inc.2011-12-21
RELIEVA SPIN SINUS DILATION SYSTEM (K111875)Acclarent, Inc.2011-10-11
PATHASSIST LIGHT FIBER (K111763)Entellus Medical, Inc.2011-09-15
RELIEVA SOLO ELITE SINUS BALLOON CATHETER (K111254)Acclarent, Inc.2011-08-22
ENTELLUS MEDICAL SINUS GUIDEWIRE (K110739)Entellus Medical, Inc.2011-06-14
ILLUMINATING SINUS SEEKER (K110158)Entellus Medical, Inc.2011-06-07
XPRESS BALLOON DEVICE (K102003)Entellus Medical, Inc.2010-10-22
ENTELLUS MEDICAL BALLOON DEVICE (K093007)Entellus Medical, Inc.2010-02-05
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) (K091681)Entellus Medical, Inc.2009-07-08
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM (K081542)Entellus Medical, Inc.2008-06-27
ENTELLUS MEDICAL RS-SERIES SYSTEM (K072302)Entellus Medical, Inc.2008-04-08
RELIEVA SINUS BALLOON CATHETER (K061903)Acclarent, Inc.2006-08-18
RELIEVA SINUS BALLOON INFLATION DEVICE (K052198)Acclarent, Inc.2005-08-31
RELIEVA SINUS BALLOON DILATION CATHETER (K043527)Exploramed Nc1, Inc.2005-04-05
EXMOOR SUCTION CLEARANCE KIT (K990366)Exmoor Plastics , Ltd.1999-03-05
FAST TRACT TRANSTRACHEAL PROCEDURE KIT (K970018)L.W. Ward and Assoc., Inc.1997-03-28
EXMOOR SINGLE USE MYRINGOTOMES (K942745)Exmoor Plastics , Ltd.1994-09-02
SUCKER ENDS (ZOELLNER) (K942746)Exmoor Plastics , Ltd.1994-08-24
DISPOSABLE NASAL SCISSOR (K942063)United States Surgical, A Division of Tyco Healthc1994-06-08
DISPOSABLE NASAL RONGEUR (K942064)United States Surgical, A Division of Tyco Healthc1994-06-08
DISPOSABLE ENT PUNCH (K942065)United States Surgical, A Division of Tyco Healthc1994-06-06
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (K933770)Mahe-Medizintechnik1994-03-23
SYMBIOSIS ENT SURGICAL INSTRUMENTS (K931793)Symbiosis Corp.1993-07-22
HOUSE-BELLUCCI ALLIGATOR SCISSORS (K930292)Thomasville Medical Assoc.1993-03-19
ATMOS MIRROR WARMER (K920988)Jedmed Instrument Co.1992-05-15
'EXMOOR' SINGLE USE SUCTION TUBE (K892504)Exmoor Plastics , Ltd.1989-06-22
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) (K884631)Xomed, Inc.1989-03-22
POREX OTOLOGY INSTRUMENTS (K873044)Porex Medical1987-09-04
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR (K864938)Exmoor Plastics , Ltd.1987-03-23

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Every clearance here is in the API, with alerts when new ones post.