EMX · Class I · 21 CFR 874.4100

FDA Product Code EMX: Balloon, Epistaxis

Leading manufacturers include Ultracell Medical Technologies, Inc., Boston Medical Products, Inc. and Smith & Nephew Richards, Inc..

47
Total
47
Cleared
107d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Balloon, Epistaxis Devices (Product Code EMX)

47 devices
1–24 of 47
Cleared Nov 14, 2022
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326
Hemostasis, LLC
Ear, Nose, Throat · 283d
Cleared Feb 02, 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731
Xomed, Inc.
Ear, Nose, Throat · 181d
Cleared Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
K973085
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 92d
Cleared Aug 04, 1997
RHINOCELL NASAL PACKINGS
K972459
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 10, 1997
POST-STOP EPISTAXIS CATHETER
K972078
Boston Medical Products, Inc.
Ear, Nose, Throat · 37d
Cleared Jun 26, 1997
EPI-MAX EPISTAXIS CATHETER
K972076
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Jun 26, 1997
EPI-STOP EPISTAXIS CATHETER
K972077
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Nov 15, 1995
HYDROCELL NASAL AND SINUS PACKS
K954491
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 49d
Cleared Feb 17, 1995
EPISTAXIS BALLOON CATHETER WITH PACKING
K945554
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 95d
Cleared Jan 18, 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 65d
Cleared Feb 12, 1993
NASAL-SINUS PACKING
K924542
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 157d
Cleared Nov 30, 1992
ULTRACELL NASAL PACKING
K920358
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 308d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
K900583
Bivona Medical Technologies
Ear, Nose, Throat · 183d
Cleared Aug 17, 1984
FOX POST NASAL BALLOON CATHETER
K841040
Inmed Corp.
Ear, Nose, Throat · 158d
Cleared Jun 14, 1982
EPISTAXIS CATHETER/KIT
K821584
Bivona Medical Technologies
Ear, Nose, Throat · 13d
Cleared Jun 16, 1981
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496
Narco Scientific
Ear, Nose, Throat · 20d
Cleared Feb 21, 1980
NASOSTAT
K800175
Edward Weck, Inc.
Ear, Nose, Throat · 24d

About Product Code EMX - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code EMX since 1978, with 47 receiving FDA clearance (average review time: 107 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.