Cannula, Sinus
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
61 adverse event reports on file
- RELIEVA STRATUS ETHMOID MICROFLOW SPACERJul 21, 2016InjuryAcclarent, Inc.3005172759-2016-00013
- RELIEVA VORTEX 2 SINUS IRRIGATION CATHETERMay 5, 2016InjuryAcclarent, Inc.3005172759-2016-00009
- RELIEVA FLEX SINUS GUIDE CATHETERApr 11, 2016InjuryAcclarent, Inc.3005172759-2016-00008
- RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEMDec 3, 2015MalfunctionAcclarent, Inc.3005172759-2015-00018
- UNKNOWNSep 25, 2015InjuryAcclarent, Inc.3005172759-2015-00013
- RELIEVA FLEX SINUS GUIDE CATHETERAug 15, 2015MalfunctionAcclarent, Inc.3005172759-2015-00011
- RELIEVA FLEX SINUS GUIDE CATHETERDec 31, 2014MalfunctionAcclarent3005172759-2014-00033
- RELIEVA FLEX SINUS GUIDE CATHETERDec 5, 2014MalfunctionAcclarent3005172759-2014-00032
- RELIEVA SPIN SINUS GUIDE CATHETER TIPNov 12, 2014MalfunctionAcclarent3005172759-2014-00031
- RELIEVA VORTEX 2 SINUS IRRIGATION CATHETEROct 6, 2014InjuryAcclarent3005172759-2014-00027
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Acclarent, Inc.TerminatedJun 9, 2015
RELIEVA FLEX Sinus Guide Catheter F-70.
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Z-1740-2015 · View FDA record ↗ - Surgical Instrument Service And Savings, Inc.TerminatedJul 1, 2013
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Z-1639-2013 · View FDA record ↗
Registered firms
62 firms currently registered for this product code
Garish Apparels
Wazirabad Punjab, PK
Gyrus Acmi, Inc.
Westborough, MA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Synergy Health Ast, Srl
Alajuela, CR
Acclarent, Inc.
Irvine, CA, US
Erchinger Ag
TUTTLINGEN Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Instrumentarium Surgical Corp., Inc.
TERREBONNE Quebec, CA
Premier Medical
PHILADELPHIA, PA, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
BUFFALO, NY, US
Boston Medical Products, Inc.
Shrewsbury, MA, US
Bausch & Lomb Incorporated
Manchester, MO, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Orchid Unique
Bridgeport, MI, US
Biomerics Alajuela
ALAJUELA, CR
Hive International Pvt Ltd.
Sialkot Punjab, PK
Pms Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Medetz Surgical Instruments
Jupiter, FL, US
Mentor Texas Lp
Coppell, TX, US
Integra Lifesciences Corporation
CINCINNATI, OH, US
510(k) clearances
19 clearances for this product code
- Acclarent, Inc.Oct 7, 2011
K110687 · RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
- Acclarent, Inc.Mar 3, 2010
K093594 · MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
- Acclarent, Inc.Jan 29, 2009
K083574 · RELIEVA STRATUS MICROFLOW SPACER
- Acclarent, Inc.Mar 19, 2008
K072891 · SINUS SPACER
- Acclarent, Inc.Mar 11, 2008
K073041 · RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
- Acclarent, Inc.Sep 28, 2007
K071845 · RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
- Acclarent, Inc.Sep 15, 2006
K062458 · ETHMOID SINUS SPACER
- Acclarent, Inc.May 5, 2006
K060974 · RELIENT NAVIGATION DEVICE