DeviceClearance

Product code ETF— Ear, Nose, Throat

#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES

Classification name
Unit, Examining/Treatment, Ent
Device class
Class 1
Regulation
21 CFR 874.5300
Advisory panel
Ear, Nose, Throat
Total cleared
32
First cleared
Most recent

Market context for product code ETF

FDA has cleared 32 devices under product code ETF between 1978 and 1995, filed by 13 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 ETF

Recent clearances under product code ETF

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