LYA · Class I · 21 CFR 874.4780

FDA Product Code LYA: Splint, Intranasal Septal

Leading manufacturers include Spiway, LLC, Boston Medical Products, Inc. and Polyganics B.V.,.

46
Total
46
Cleared
96d
Avg days
1983
Since
46 devices
25–46 of 46
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532
Genzyme Corp.
Ear, Nose, Throat · 85d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544
Seikagaku Corp.
Ear, Nose, Throat · 89d
Cleared Apr 13, 2001
LACTOSORB ETHMOID STENT
K002131
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 273d
Cleared Jul 02, 1998
POREX NOSTRIL RETAINERS
K981374
Porex Surgical, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 02, 1998
SILIMED NASAL RETAINER
K980221
Silimed, LLC
Ear, Nose, Throat · 70d
Cleared Jul 15, 1997
BIVALVE NASAL SPLINT
K972096
Boston Medical Products, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 08, 1997
NASAL AIRWAY SPLINT
K972092
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 07, 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151
Boston Medical Products, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 03, 1997
CUSTOM NASAL SPLINT
K972082
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 14, 1995
ENT PACKINGS, WICKS, WIPES, AND SPONGES
K954449
Oasis
Ear, Nose, Throat · 81d
Cleared Aug 11, 1995
C-FLEX SEPTAL SPLINTS
K952226
Trebay Medical Corp.
Ear, Nose, Throat · 91d
Cleared Jun 07, 1995
NASAL SEPTAL SPLINT
K952207
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 19, 1995
NASAL SPLINT
K945555
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 66d
Cleared Jul 01, 1994
BIVONA NASAL TURBINATE STENT
K935053
Bivona Medical Technologies
Ear, Nose, Throat · 253d
Cleared Mar 04, 1994
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658
Merocel Corp.
Ear, Nose, Throat · 100d
Cleared Aug 17, 1993
MEROCEL MEROSPLINT
K933152
Merocel Corp.
Ear, Nose, Throat · 49d
Cleared Jan 15, 1993
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
K925173
Westmed Intl.
Ear, Nose, Throat · 93d
Cleared Jul 23, 1992
NASAL SEPTAL SPLINT
K921195
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
TURBINATE NASAL SPLINT
K921202
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jun 14, 1990
INVOTEC BI-VALVE SPLINT
K901306
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
PASSAGE AIRWAY SPLINT
K901307
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Mar 24, 1983
FLORET NASAL TAMPON
K830263
Ritmed, Inc.
General & Plastic Surgery · 58d