Atlas FDA

KAM

19 FDA 510(k) clearances · Product code

85 daysmedian time to decision
280 days90th percentile
19clearances measured

FDA profile

Official device name
Cannula, Sinus
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2009: 5 · 2010: 12 · 2011: 8 · 2012: 9 · 2013: 7 · 2014: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (K110687)Acclarent, Inc.2011-10-07
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594)Acclarent, Inc.2010-03-03
RELIEVA STRATUS MICROFLOW SPACER (K083574)Acclarent, Inc.2009-01-29
SINUS SPACER (K072891)Acclarent, Inc.2008-03-19
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041)Acclarent, Inc.2008-03-11
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (K071845)Acclarent, Inc.2007-09-28
ETHMOID SINUS SPACER (K062458)Acclarent, Inc.2006-09-15
RELIENT NAVIGATION DEVICE (K060974)Acclarent, Inc.2006-05-05
MICROMEDICS SPHENOID SINUS STENT (K050340)Micromedics, Inc.2005-04-27
FRONTAL SINUS TREPHINATION CANNULA (K994262)Xomed, Inc.2000-02-08
XOMED T-STENT, FRONTAL SINUS STENT (K973273)Xomed, Inc.1997-09-29
ROSSITER SINUS STENT (K951803)Smith & Nephew Richards, Inc.1995-05-11
RAINS FRONTAL SINUS STENT (K951066)Smith & Nephew Richards, Inc.1995-04-04
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM (K942495)Atos Medical AB1995-02-21
SALMAN SINUS BUTTON (K922902)Boston Medical Products, Inc.1993-05-18
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS (K922145)Atos Medical AB1993-01-21
SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE (K912418)Micromedics, Inc.1991-12-20
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM (K896630)Atos Medical AB1990-06-06
MAXILL-AIR SINUS VENTILATION TUBE (K813474)Xomed, Inc.1982-01-12

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