ENWClass I

Catheter, Nasopharyngeal

21 CFR 874.4175 / Ear, Nose, Throat

ENW is the FDA product code for Catheter, Nasopharyngeal, a class I device type, regulated under 21 CFR 874.4175. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1985-07-22, and no recalls.

Classification record

Product code: ENW
Device name: Catheter, Nasopharyngeal
Regulation: 21 CFR 874.4175
Device class: Class I
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code ENW

By decision year

2 clearances under product code ENW with a decision year between 1983 and 1985, 1983 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ENW by decision year
Year	Clearances
1983	1
1985	1

Applicants with the most clearances

Product code ENW

Applicants holding the most 510(k) clearances under product code ENW
Applicant	Clearances
American V. Mueller	1
Axiom Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code ENW

Recent recalls

Product code ENW

FDA records show no recalls under product code ENW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)