KAM · Class I · 21 CFR 878.4800

FDA Product Code KAM: Cannula, Sinus

Leading manufacturers include Acclarent, Inc., Xomed, Inc. and Smith & Nephew Richards, Inc..

19
Total
19
Cleared
122d
Avg days
1982
Since

FDA 510(k) Cleared Cannula, Sinus Devices (Product Code KAM)

19 devices
1–19 of 19
Cleared Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
K110687
Acclarent, Inc.
General & Plastic Surgery · 210d
Cleared Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
K093594
Acclarent, Inc.
General & Plastic Surgery · 104d
Cleared Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
K083574
Acclarent, Inc.
General & Plastic Surgery · 57d
Cleared Mar 19, 2008
SINUS SPACER
K072891
Acclarent, Inc.
General & Plastic Surgery · 161d
Cleared Mar 11, 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
K073041
Acclarent, Inc.
General & Plastic Surgery · 134d
Cleared Sep 28, 2007
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
K071845
Acclarent, Inc.
General & Plastic Surgery · 85d
Cleared Sep 15, 2006
ETHMOID SINUS SPACER
K062458
Acclarent, Inc.
General & Plastic Surgery · 23d
Cleared May 05, 2006
RELIENT NAVIGATION DEVICE
K060974
Acclarent, Inc.
General & Plastic Surgery · 25d
Cleared Feb 08, 2000
FRONTAL SINUS TREPHINATION CANNULA
K994262
Xomed, Inc.
General & Plastic Surgery · 53d
Cleared Sep 29, 1997
XOMED T-STENT, FRONTAL SINUS STENT
K973273
Xomed, Inc.
General & Plastic Surgery · 27d
Cleared May 11, 1995
ROSSITER SINUS STENT
K951803
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 22d
Cleared Apr 04, 1995
RAINS FRONTAL SINUS STENT
K951066
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 27d
Cleared Jan 12, 1982
MAXILL-AIR SINUS VENTILATION TUBE
K813474
Xomed, Inc.
General & Plastic Surgery · 42d

About Product Code KAM - Regulatory Context