LRC · Class I · 21 CFR 874.4420

FDA Product Code LRC: Instrument, Ent Manual Surgical

Leading manufacturers include Entellus Medical, Inc., Acclarent, Inc. and Exmoor Plastics , Ltd..

65
Total
65
Cleared
102d
Avg days
1987
Since
65 devices
49–65 of 65
Cleared Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
K052198
Acclarent, Inc.
Ear, Nose, Throat · 19d
Cleared Apr 05, 2005
RELIEVA SINUS BALLOON DILATION CATHETER
K043527
Exploramed Nc1, Inc.
Ear, Nose, Throat · 105d
Cleared Mar 05, 1999
EXMOOR SUCTION CLEARANCE KIT
K990366
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 28d
Cleared Mar 28, 1997
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K970018
L.W. Ward and Assoc., Inc.
Ear, Nose, Throat · 85d
Cleared Sep 02, 1994
EXMOOR SINGLE USE MYRINGOTOMES
K942745
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 84d
Cleared Aug 24, 1994
SUCKER ENDS (ZOELLNER)
K942746
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 75d
Cleared Jun 08, 1994
DISPOSABLE NASAL SCISSOR
K942063
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 40d
Cleared Jun 08, 1994
DISPOSABLE NASAL RONGEUR
K942064
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 40d
Cleared Jun 06, 1994
DISPOSABLE ENT PUNCH
K942065
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 38d
Cleared Jul 22, 1993
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793
Symbiosis Corp.
Ear, Nose, Throat · 101d
Cleared Mar 19, 1993
HOUSE-BELLUCCI ALLIGATOR SCISSORS
K930292
Thomasville Medical Assoc.
Ear, Nose, Throat · 57d
Cleared May 15, 1992
ATMOS MIRROR WARMER
K920988
Jedmed Instrument Co.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1989
'EXMOOR' SINGLE USE SUCTION TUBE
K892504
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Mar 22, 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K884631
Xomed, Inc.
Ear, Nose, Throat · 135d
Cleared Mar 23, 1987
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR
K864938
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 97d