ESEClass I

Larynx, Artificial (Battery-Powered)

21 CFR 874.3375 / Ear, Nose, Throat

ESE is the FDA product code for Larynx, Artificial (Battery-Powered), a class I device type, regulated under 21 CFR 874.3375. As of 2026-09-10, FDA records hold 13 510(k) clearances under this code, the most recent dated 1994-03-16, and no recalls.

Classification record

Product code: ESE
Device name: Larynx, Artificial (Battery-Powered)
Regulation: 21 CFR 874.3375
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: 13
Ingested recalls: 0

Clearances, product code ESE

By decision year

13 clearances under product code ESE with a decision year between 1983 and 1994, 1984 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code ESE by decision year
Year	Clearances
1983	2
1984	3
1985	1
1986	2
1990	1
1993	3
1994	1

Applicants with the most clearances

Product code ESE

Applicants holding the most 510(k) clearances under product code ESE
Applicant	Clearances
Bloomfield Research and Development, Inc.	2
Bear Medical Systems, Inc.	1
Bruce Medical Supply	1
Cisko Systems	1
Denrick Corp.	1
Dynamed Audio, Inc.	1
Kells Medical, Inc.	1
Mountain Precision Mfg. Ltd. Co.	1
Respiratory Support Products, Inc.	1
Stanton Magnetics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code