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.
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| 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 |
Top Applicants
- Shippert Medical Technologies Corp. — 5 clearances
- Ultracell Medical Technologies, Inc. — 5 clearances
- Boston Medical Products, Inc. — 4 clearances
- Bivona Medical Technologies — 2 clearances
- Invotec International, Inc. — 2 clearances
