Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4780](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4780) → QJL — Splint, Intranasal Septal, Cber Led

# QJL · Splint, Intranasal Septal, Cber Led

_Ear, Nose, Throat · 21 CFR 874.4780 · Class 1_

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

## Overview

- **Product Code:** QJL
- **Device Name:** Splint, Intranasal Septal, Cber Led
- **Regulation:** [21 CFR 874.4780](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4780)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K160101](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/QJL/K160101.md) | SinuBand | Bioinspire Technologies, Incorporated | Jul 27, 2016 | SESE |

## Top Applicants

- Bioinspire Technologies, Incorporated — 1 clearance

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

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