Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart F — Therapeutic Devices](/submissions/EN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 874.5800](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5800) → EPP — Splint, Nasal

# EPP · Splint, Nasal

_Ear, Nose, Throat · 21 CFR 874.5800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP

## Overview

- **Product Code:** EPP
- **Device Name:** Splint, Nasal
- **Regulation:** [21 CFR 874.5800](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5800)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

## 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 the limitations in § 874.9.

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942158](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K942158.md) | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT  PATTERNS AND SPLINT KITS | Wfr/Aquaplast Corp. | Jul 29, 1994 | SESE |
| [K942724](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K942724.md) | EXTERNAL NASAL SPLINT | Micromed Development Corp. | Jul 8, 1994 | SESE |
| [K895502](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K895502.md) | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Microbio-Medics, Inc. | Dec 8, 1989 | SESE |
| [K890599](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K890599.md) | HOOD NASAL SPLINT | Hood Laboratories | Mar 17, 1989 | SESE |
| [K882244](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K882244.md) | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | Richards Medical Co., Inc. | Jun 23, 1988 | SESE |
| [K872905](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K872905.md) | AMERICAN NASAL SPONGE | American Silk Sutures, Inc. | Sep 4, 1987 | SESE |
| [K864933](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K864933.md) | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| [K864932](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K864932.md) | 'EXMOOR' CAWOOD NASAL SPLINTS | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| [K864930](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K864930.md) | 'EXMOOR' ATKINS NASAL SPLINT | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| [K864934](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K864934.md) | 'EXMOOR' SHAH SILICONE DISCS | Exmoor Plastics , Ltd. | Jan 28, 1987 | SESE |
| [K863382](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K863382.md) | CANNON NASAL SPLINT | Treace Medical, Inc. | Oct 7, 1986 | SESE |
| [K862496](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K862496.md) | MICROTEK INTRANASAL SPLINT | Microtek Medical, Inc. | Jul 14, 1986 | SESE |
| [K810738](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K810738.md) | GOODE MAGNETIC NASAL SPLINT | Xomed, Inc. | Mar 31, 1981 | SESE |
| [K791681](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K791681.md) | THE DENVER SPLINT | Xomed, Inc. | Oct 22, 1979 | SESE |
| [K791053](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP/K791053.md) | THE DENVER SPLINT | Ronald D. Shippert, M.D. | Aug 16, 1979 | SESE |

## Top Applicants

- Exmoor Plastics , Ltd. — 4 clearances
- Xomed, Inc. — 2 clearances
- American Silk Sutures, Inc. — 1 clearance
- Hood Laboratories — 1 clearance
- Microbio-Medics, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/EPP)

**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