Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4680](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4680) → QNW — Reprocessed Bronchoscope

# QNW · Reprocessed Bronchoscope

_Ear, Nose, Throat · 21 CFR 874.4680 · Class 2_

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

## Overview

- **Product Code:** QNW
- **Device Name:** Reprocessed Bronchoscope
- **Regulation:** [21 CFR 874.4680](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4680)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231473](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/QNW/K231473.md) | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | Nov 28, 2023 | SESE |
| [K203614](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/QNW/K203614.md) | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | Mar 11, 2021 | SESE |

## Top Applicants

- Auris Health, Inc., A Johnson and Johnson Family Company — 2 clearances

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

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