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) → ENW — Catheter, Nasopharyngeal

# ENW · Catheter, Nasopharyngeal

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

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

## Overview

- **Product Code:** ENW
- **Device Name:** Catheter, Nasopharyngeal
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K851082](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW/K851082.md) | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | American V. Mueller | Jul 22, 1985 | SESE |
| [K832476](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW/K832476.md) | SILICONE SOFT-PAK EPISTAXIS CATHETER | Axiom Medical, Inc. | Nov 3, 1983 | SESE |

## Top Applicants

- American V. Mueller — 1 clearance
- Axiom Medical, Inc. — 1 clearance

---

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

**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