Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4100](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4100) → EMX — Balloon, Epistaxis # EMX · Balloon, Epistaxis _Ear, Nose, Throat · 21 CFR 874.4100 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX ## Overview - **Product Code:** EMX - **Device Name:** Balloon, Epistaxis - **Regulation:** [21 CFR 874.4100](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4100) - **Device Class:** 1 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K220326.md) | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | Nov 14, 2022 | SESE | | [K041446](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K041446.md) | NASALCEASE | Les Laboratorires Brothier, S.A. | Jul 1, 2004 | SESE | | [K000108](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K000108.md) | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | Bhk Holding | May 23, 2000 | SESE | | [K993362](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K993362.md) | HYLASINE | Biomatrix, Inc. | Mar 13, 2000 | SESE | | [K983276](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K983276.md) | HYDROFERA BACTERISTATIC NASAL DRESSING | Hydrofera, LLC | Sep 14, 1999 | SESE | | [K982731](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K982731.md) | MEROGEL NASAL DRESSING AND SINUS STENT | Xomed, Inc. | Feb 2, 1999 | SESE | | [K984069](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K984069.md) | ENTAXIS NASAL PACKING | Les Laboratorires Brothier, S.A. | Jan 25, 1999 | SESE | | [K981966](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K981966.md) | NOSEBLEED NOSECLIP | Michael M. Knott, M.D. | Aug 14, 1998 | SESE | | [K973656](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K973656.md) | DISPOSABLE SILICONE EPISTAXIS CATHETER | Specialty Surgical Products, Inc. | Nov 18, 1997 | SESE | | [K973085](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K973085.md) | ULTRACELL PACKING WITH SLEEVE | Ultracell Medical Technologies, Inc. | Nov 18, 1997 | SESE | | [K972922](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972922.md) | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K | Interview Medical Technology Corp. | Oct 8, 1997 | SESE | | [K972459](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972459.md) | RHINOCELL NASAL PACKINGS | Boston Medical Products, Inc. | Aug 4, 1997 | SESE | | [K972078](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972078.md) | POST-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jul 10, 1997 | SESE | | [K972077](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972077.md) | EPI-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jun 26, 1997 | SESE | | [K972076](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K972076.md) | EPI-MAX EPISTAXIS CATHETER | Boston Medical Products, Inc. | Jun 26, 1997 | SESE | | [K971411](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K971411.md) | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K | Bentec Medical, Inc. | Jun 3, 1997 | SESE | | [K971000](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K971000.md) | EPISTAXIS NASAL PACK | Invotec International, Inc. | May 14, 1997 | SESE | | [K964113](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K964113.md) | 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](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K963856.md) | RAND NASAL PACKING | Rand Scientific Corp. | Oct 18, 1996 | SESE | | [K962133](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K962133.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com