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ETD — Tube, Tympanostomy Class II

FDA Device Classification

Classification Details

Product Code
ETD
Device Class
Class II
Regulation Number
874.3880
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250256aventamed dacSolo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube April 28, 2025
K232702aventamed dacSolo+ Tympanostomy Tube Device (TTD)May 20, 2024
K233658biowy corporationBiowy Tym Tube (TT)February 16, 2024
K232059grace medicalTympanostomy TubesNovember 24, 2023
K221254preceptis medicalHummingbird Tympanostomy Tube SystemJuly 27, 2022
K200952preceptis medicalHummingbird Tympanostomy Tube SystemJune 5, 2020
K171239tusker medicalTULA Tube Delivery SystemJune 28, 2017
K151830preceptis medicalHummingbird Tympanostomy TubeSeptember 21, 2015
K151067medtronic xomedVentilation (Tympanostomy) TubesJuly 22, 2015
K142282preceptis medicalHUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)April 23, 2015
K133921preceptis medicalPRECEPTIS TYMPANOSTOMY TUBE INSERTERAugust 22, 2014
K103595acclarentACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEMApril 1, 2011
K082188acclarentTYMPANOSTOMY TUBESeptember 19, 2008
K071150heinz kurz gmbh medizintechnikTROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076December 12, 2007
K071178otomedics advanced medical technologiesOTOMEDICS SOFT TYMPANOSTOMY TUBEJune 22, 2007
K062672grace medicalGRACE MEDICAL PC COATED TYMPANOSTOMY TUBESOctober 24, 2006
K062385grace medicalBLUE PTFE (FLUOROPLASTIC) VENTILATION TUBESSeptember 27, 2006
K061058adept medicalNEOZOLINE VENTILATION TUBESJuly 12, 2006
K011383durectMICRODOSE CATH, MODELS 90121-201, -202, -203June 25, 2001
K000801gyrus entPC COATED FLUOROPLASTIC VENT TUBESJune 19, 2000