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 Les Laboratorires Brothier, S.A..

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 Jul 01, 2004
NASALCEASE
K041446
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 30d
Cleared May 23, 2000
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
K000108
Bhk Holding
Ear, Nose, Throat · 130d
Cleared Mar 13, 2000
HYLASINE
K993362
Biomatrix, Inc.
Ear, Nose, Throat · 159d
Cleared Sep 14, 1999
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276
Hydrofera, LLC
Ear, Nose, Throat · 362d
Cleared Feb 02, 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731
Xomed, Inc.
Ear, Nose, Throat · 181d
Cleared Jan 25, 1999
ENTAXIS NASAL PACKING
K984069
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 70d
Cleared Aug 14, 1998
NOSEBLEED NOSECLIP
K981966
Michael M. Knott, M.D.
Ear, Nose, Throat · 71d
Cleared Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
K973085
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 92d
Cleared Nov 18, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656
Specialty Surgical Products, Inc.
Ear, Nose, Throat · 54d
Cleared Oct 08, 1997
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K
K972922
Interview Medical Technology Corp.
Ear, Nose, Throat · 61d
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 Jun 03, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
K971411
Bentec Medical, Inc.
Ear, Nose, Throat · 48d
Cleared May 14, 1997
EPISTAXIS NASAL PACK
K971000
Invotec International, Inc.
Ear, Nose, Throat · 56d
Cleared Nov 07, 1996
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL
K964113
M-Pact Worldwide Management Corp.
Ear, Nose, Throat · 23d
Cleared Oct 18, 1996
RAND NASAL PACKING
K963856
Rand Scientific Corp.
Ear, Nose, Throat · 23d
Cleared Aug 01, 1996
EXPANDACELL INJECTO-PAK
K962133
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 59d
Cleared Feb 27, 1996
EXPANDACELL INJECTO-PAK NASAL PACK
K960228
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 41d
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

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.