Product Code: EMX FDA class 1 21 CFR 874.4100

Balloon, Epistaxis

Ear, Nose, Throat

The epistaxis balloon is an inflatable device inserted into the nasal cavity to apply pressure and control nosebleeds that cannot be managed by conventional methods. It is classified as FDA Class 1, meaning it poses the lowest risk and is subject only to general controls. The product code is EMX, regulated under 21 CFR 874.4100 in the Ear, Nose, Throat specialty. No special regulatory flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EMX
Device Class: FDA class 1
Regulation Number: 874.4100
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220326	PosiSep X BAM Hemostat Dressing/Intranasal Splint	Nov 14, 2022	Substantially Equivalent	Hemostasis, LLC
K041446	NASALCEASE	Jul 01, 2004	Substantially Equivalent	Les Laboratorires Brothier, S.A.
K000108	RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100	May 23, 2000	Substantially Equivalent	Bhk Holding
K993362	HYLASINE	Mar 13, 2000	Substantially Equivalent	Biomatrix, Inc.
K983276	HYDROFERA BACTERISTATIC NASAL DRESSING	Sep 14, 1999	Substantially Equivalent	Hydrofera, LLC
K982731	MEROGEL NASAL DRESSING AND SINUS STENT	Feb 02, 1999	Substantially Equivalent	Xomed, Inc.
K984069	ENTAXIS NASAL PACKING	Jan 25, 1999	Substantially Equivalent	Les Laboratorires Brothier, S.A.
K981966	NOSEBLEED NOSECLIP	Aug 14, 1998	Substantially Equivalent	Michael M. Knott, M.D.
K973656	DISPOSABLE SILICONE EPISTAXIS CATHETER	Nov 18, 1997	Substantially Equivalent	Specialty Surgical Products, Inc.
K973085	ULTRACELL PACKING WITH SLEEVE	Nov 18, 1997	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K972922	VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K	Oct 08, 1997	Substantially Equivalent	Interview Medical Technology Corp.
K972459	RHINOCELL NASAL PACKINGS	Aug 04, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972078	POST-STOP EPISTAXIS CATHETER	Jul 10, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972077	EPI-STOP EPISTAXIS CATHETER	Jun 26, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972076	EPI-MAX EPISTAXIS CATHETER	Jun 26, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K971411	DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K	Jun 03, 1997	Substantially Equivalent	Bentec Medical, Inc.
K971000	EPISTAXIS NASAL PACK	May 14, 1997	Substantially Equivalent	Invotec International, Inc.
K964113	IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL	Nov 07, 1996	Substantially Equivalent	M-Pact Worldwide Management Corp.
K963856	RAND NASAL PACKING	Oct 18, 1996	Substantially Equivalent	Rand Scientific Corp.
K962133	EXPANDACELL INJECTO-PAK	Aug 01, 1996	Substantially Equivalent	Shippert Medical Technologies Corp.
K960228	EXPANDACELL INJECTO-PAK NASAL PACK	Feb 27, 1996	Substantially Equivalent	Shippert Medical Technologies Corp.
K955593	EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY	Dec 22, 1995	Substantially Equivalent	Shippert Medical Technologies Corp.
K954845	EXPANDACELL INJECTO-PAK NASAL PACK	Nov 27, 1995	Substantially Equivalent	Shippert Medical Technologies Corp.
K954491	HYDROCELL NASAL AND SINUS PACKS	Nov 15, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950024	EXPANDACELL NASAL PACK WITH AIRWAY	Feb 17, 1995	Substantially Equivalent	Shippert Medical Technologies Corp.
K945554	EPISTAXIS BALLOON CATHETER WITH PACKING	Feb 17, 1995	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K945556	ANTERIOR/POSTERIOR EPISTAXIS CATHETER	Jan 18, 1995	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K943718	EPISTAT-II NASAL CATHETER	Sep 16, 1994	Substantially Equivalent	Merocel Corp.
K933800	FLUOROFILM(R)	Jun 24, 1994	Substantially Equivalent	American Custom Medical, Inc.
K935724	THE EXPANDACELL SINUS PACK	May 12, 1994	Substantially Equivalent	Denver Splint Co.
K924944	INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA	Jul 02, 1993	Substantially Equivalent	Westmed Intl.
K920394	MEROCEL EPISTACIS KIT	Mar 18, 1993	Substantially Equivalent	Merocel Corp.
K924542	NASAL-SINUS PACKING	Feb 12, 1993	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K920358	ULTRACELL NASAL PACKING	Nov 30, 1992	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K921199	EPISTAXIS NASAL BALLOON CATHETER	Jul 08, 1992	Substantially Equivalent	Smith & Nephew Richards, Inc.
K912524	EXPANDACEL NASAL TAMPONS, MODIFICATION	Aug 15, 1991	Substantially Equivalent	Surgitrend, Ltd.
K904624	EXPANDACEL NASAL TAMPONS	Mar 21, 1991	Substantially Equivalent	Ron Shippert, MD
K900583	MODIFIED BIVONA EPISTAXIS CATHETER	Aug 09, 1990	Substantially Equivalent	Bivona Medical Technologies
K901310	ULTRASTAT NASAL CATHETER	Jun 14, 1990	Substantially Equivalent	Invotec International, Inc.
K900171	EXPANDACEL NASAL TAMPONS	Jun 14, 1990	Substantially Equivalent	Surgitrend, Ltd.
K896248	INNOVATIONS NASAL TAMPON	Apr 13, 1990	Substantially Equivalent	Innovations by Necessity, Inc.
K841040	FOX POST NASAL BALLOON CATHETER	Aug 17, 1984	Substantially Equivalent	Inmed Corp.
K821584	EPISTAXIS CATHETER/KIT	Jun 14, 1982	Substantially Equivalent	Bivona Medical Technologies
K811496	GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.	Jun 16, 1981	Substantially Equivalent	Narco Scientific
K800175	NASOSTAT	Feb 21, 1980	Substantially Equivalent	Edward Weck, Inc.
K781615	NASOSTAT	Oct 11, 1978	Substantially Equivalent	Nasostat, Inc.
K781631	ECHO-OIL	Oct 10, 1978	Substantially Equivalent	Echo Laboratories, Inc.