510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ETPClass I

Stimulator, Caloric-Water

21 CFR 874.1800 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ETP is the FDA product code for Stimulator, Caloric-Water, a class I device type, regulated under 21 CFR 874.1800. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
ETP
Device name
Stimulator, Caloric-Water
Regulation
21 CFR 874.1800
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
6
Ingested recalls
2

Clearances, product code ETP

By decision year
6 clearances under product code ETP with a decision year between 1980 and 1986, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code ETP by decision year
YearClearances
19802
19823
19861

Applicants with the most clearances

Product code ETP
Applicants holding the most 510(k) clearances under product code ETP
ApplicantClearances
JEDMED Instrument Company4
Ethicare Products1
Life-Tech Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code