EMX · Balloon, Epistaxis
Ear, Nose, Throat · 21 CFR 874.4100 · Class 1
Overview
| Product Code | EMX |
|---|---|
| Device Name | Balloon, Epistaxis |
| Regulation | 21 CFR 874.4100 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
Cleared Devices (47)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | Nov 14, 2022 | SESE |
| K041446 | NASALCEASE | Les Laboratorires Brothier, S.A. | Jul 1, 2004 | SESE |
| K000108 | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | Bhk Holding | May 23, 2000 | SESE |
| K993362 | HYLASINE | Biomatrix, Inc. | Mar 13, 2000 | SESE |
| K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | Hydrofera, LLC | Sep 14, 1999 | SESE |
| K982731 | MEROGEL NASAL DRESSING AND SINUS STENT | Xomed, Inc. | Feb 2, 1999 | SESE |
| K984069 | ENTAXIS NASAL PACKING | Les Laboratorires Brothier, S.A. | Jan 25, 1999 | SESE |
| K981966 | NOSEBLEED NOSECLIP | Michael M. Knott, M.D. | Aug 14, 1998 | SESE |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | Specialty Surgical Products, Inc. | Nov 18, 1997 | SESE |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Ultracell Medical Technologies, Inc. | Nov 18, 1997 | SESE |
| K972922 | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K | Interview Medical Technology Corp. | Oct 8, 1997 | SESE |
| K972459 | RHINOCELL NASAL PACKINGS | Boston Medical Products, Inc. | Aug 4, 1997 | SESE |
| K972078 | POST-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jul 10, 1997 | SESE |
| K972077 | EPI-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jun 26, 1997 | SESE |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jun 26, 1997 | SESE |
| K971411 | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K | Bentec Medical, Inc. | Jun 3, 1997 | SESE |
| K971000 | EPISTAXIS NASAL PACK | Invotec International, Inc. | May 14, 1997 | SESE |
| K964113 | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL | M-Pact Worldwide Management Corp. | Nov 7, 1996 | SESE |
| K963856 | RAND NASAL PACKING | Rand Scientific Corp. | Oct 18, 1996 | SESE |
| K962133 | EXPANDACELL INJECTO-PAK | Shippert Medical Technologies Corp. | Aug 1, 1996 | SESE |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | Feb 27, 1996 | SESE |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | Shippert Medical Technologies Corp. | Dec 22, 1995 | SESE |
| K954845 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | Nov 27, 1995 | SESE |
| K954491 | HYDROCELL NASAL AND SINUS PACKS | Smith & Nephew Richards, Inc. | Nov 15, 1995 | SESE |
| K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | Shippert Medical Technologies Corp. | Feb 17, 1995 | SESE |
| K945554 | EPISTAXIS BALLOON CATHETER WITH PACKING | Ultracell Medical Technologies, Inc. | Feb 17, 1995 | SESE |
| K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER | Ultracell Medical Technologies, Inc. | Jan 18, 1995 | SESE |
| K943718 | EPISTAT-II NASAL CATHETER | Merocel Corp. | Sep 16, 1994 | SESE |
| K933800 | FLUOROFILM(R) | American Custom Medical, Inc. | Jun 24, 1994 | SESE |
| K935724 | THE EXPANDACELL SINUS PACK | Denver Splint Co. | May 12, 1994 | SESE |
| K924944 | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA | Westmed Intl. | Jul 2, 1993 | SESE |
| K920394 | MEROCEL EPISTACIS KIT | Merocel Corp. | Mar 18, 1993 | SESE |
| K924542 | NASAL-SINUS PACKING | Ultracell Medical Technologies, Inc. | Feb 12, 1993 | SESE |
| K920358 | ULTRACELL NASAL PACKING | Ultracell Medical Technologies, Inc. | Nov 30, 1992 | SESE |
| K921199 | EPISTAXIS NASAL BALLOON CATHETER | Smith & Nephew Richards, Inc. | Jul 8, 1992 | SESE |
| K912524 | EXPANDACEL NASAL TAMPONS, MODIFICATION | Surgitrend, Ltd. | Aug 15, 1991 | SESE |
| K904624 | EXPANDACEL NASAL TAMPONS | Ron Shippert, MD | Mar 21, 1991 | SESE |
| K900583 | MODIFIED BIVONA EPISTAXIS CATHETER | Bivona Medical Technologies | Aug 9, 1990 | SESE |
| K901310 | ULTRASTAT NASAL CATHETER | Invotec International, Inc. | Jun 14, 1990 | SESE |
| K900171 | EXPANDACEL NASAL TAMPONS | Surgitrend, Ltd. | Jun 14, 1990 | SESE |
| K896248 | INNOVATIONS NASAL TAMPON | Innovations by Necessity, Inc. | Apr 13, 1990 | SESE |
| K841040 | FOX POST NASAL BALLOON CATHETER | Inmed Corp. | Aug 17, 1984 | SESE |
| K821584 | EPISTAXIS CATHETER/KIT | Bivona Medical Technologies | Jun 14, 1982 | SESE |
| K811496 | GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. | Narco Scientific | Jun 16, 1981 | SESE |
| K800175 | NASOSTAT | Edward Weck, Inc. | Feb 21, 1980 | SESE |
| K781615 | NASOSTAT | Nasostat, Inc. | Oct 11, 1978 | SESE |
| K781631 | ECHO-OIL | Echo Laboratories, Inc. | Oct 10, 1978 | SESE |
Top Applicants
- Ultracell Medical Technologies, Inc. — 5 clearances
- Shippert Medical Technologies Corp. — 5 clearances
- Boston Medical Products, Inc. — 4 clearances
- Surgitrend, Ltd. — 2 clearances
- Smith & Nephew Richards, Inc. — 2 clearances
