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
K973226Substantially Equivalent

Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/s, Diabolo Tympanic Ventilation Tube, Minimal T)

Heinz Kurz GmbH Medizintechnik, Dusslingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973226 is the FDA 510(k) clearance record for TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T), a class II device, cleared for Heinz Kurz GmbH Medizintechnik on under FDA product code ETD (Tube, Tympanostomy). FDA records list 14 510(k) clearances for Heinz Kurz GmbH Medizintechnik, from to . As of , FDA records show no recalls naming K973226.

Clearance record

Decision date
Received
(69 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Heinz Kurz GmbH Medizintechnik Tubinger Strasse 3, Dusslingen, DE
510(k) summary
Summary
Third party review
No

Clearances, product code ETD

Trailing 12 months
1 clearance under product code ETD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260