← Product Code [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX) · K912524

# EXPANDACEL NASAL TAMPONS, MODIFICATION (K912524)

_Surgitrend, Ltd. · EMX · Aug 15, 1991 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K912524

## Device Facts

- **Applicant:** Surgitrend, Ltd.
- **Product Code:** [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX.md)
- **Decision Date:** Aug 15, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4100
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K912524](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K912524)

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