Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4175](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4175) → KBI — Bougie, Eustachian

# KBI · Bougie, Eustachian

_Ear, Nose, Throat · 21 CFR 874.4175 · Class 1_

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

## Overview

- **Product Code:** KBI
- **Device Name:** Bougie, Eustachian
- **Regulation:** [21 CFR 874.4175](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4175)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

## 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 |
| --- | --- | --- | --- | --- |
| [K770959](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI/K770959.md) | BOUGIE, FILIFORM, JACKSON | V. Mueller O.V. Baxter Healthcare Corp. | Jun 14, 1977 | SESE |

## Top Applicants

- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance

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

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