DeviceClearance

Product code ETP— Ear, Nose, Throat

ENTHERMO IRRIGATION UNIT

Classification name
Stimulator, Caloric-Water
Device class
Class 1
Regulation
21 CFR 874.1800
Advisory panel
Ear, Nose, Throat
Total cleared
6
First cleared
Most recent

Market context for product code ETP

FDA has cleared 6 devices under product code ETP between 1980 and 1986, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code ETP

Recent clearances under product code ETP

Data sourced from openFDA. This site is unofficial and independent of the FDA.