DeviceClearance

Product code ETD— Ear, Nose, Throat

TYMPANOSTOMY TUBE

Classification name
Tube, Tympanostomy
Device class
Class 2
Regulation
21 CFR 874.3880
Advisory panel
Ear, Nose, Throat
Total cleared
116
First cleared
Most recent

Market context for product code ETD

FDA has cleared 116 devices under product code ETD between 1976 and 2026, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ETD

Recent clearances under product code ETD

1–100 of 116

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