ETFClass I

Unit, Examining/Treatment, Ent

21 CFR 874.5300 / Ear, Nose, Throat

ETF is the FDA product code for Unit, Examining/Treatment, Ent, a class I device type, regulated under 21 CFR 874.5300. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 1995-08-11, and no recalls.

Classification record

Product code: ETF
Device name: Unit, Examining/Treatment, Ent
Regulation: 21 CFR 874.5300
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: 32
Ingested recalls: 0

Clearances, product code ETF

By decision year

32 clearances under product code ETF with a decision year between 1978 and 1995, 1980 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code ETF by decision year
Year	Clearances
1978	1
1979	3
1980	8
1981	1
1982	6
1984	2
1986	2
1988	1
1990	2
1991	3
1993	1
1995	2

Applicants with the most clearances

Product code ETF

Applicants holding the most 510(k) clearances under product code ETF
Applicant	Clearances
JEDMED Instrument Company	17
Midmark Corp	3
Kelleher Corp.	2
Amsco Co.	1
Dunrich, Inc.	1
F. & F. Koenigkramer	1
Happersberger Otopront GmbH	1
Kells Medical, Inc.	1
Micromedics, Inc.	1
Premier Dental Products Co	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order