ETD — Tube, Tympanostomy

Class 2 Implant

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (115)

Device Name	Manufacturer	K-Number	Decision Date
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))	Aventamed Dac	K250256	2025-04-28
Solo+ Tympanostomy Tube Device (TTD)	Aventamed Dac	K232702	2024-05-20
Biowy Tym Tube (TT)	Biowy Corporation	K233658	2024-02-16
Tympanostomy Tubes	Grace Medical, Inc.	K232059	2023-11-24
Hummingbird Tympanostomy Tube System	Preceptis Medical, Inc.	K221254	2022-07-27
Hummingbird Tympanostomy Tube System	Preceptis Medical, Inc.	K200952	2020-06-05
TULA Tube Delivery System	Tusker Medical	K171239	2017-06-28
Hummingbird Tympanostomy Tube	Preceptis Medical	K151830	2015-09-21
Ventilation (Tympanostomy) Tubes	Medtronic Xomed, Inc.	K151067	2015-07-22
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)	Preceptis Medical	K142282	2015-04-23
PRECEPTIS TYMPANOSTOMY TUBE INSERTER	Preceptis Medical	K133921	2014-08-22
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM	Acclarent, Inc.	K103595	2011-04-01
TYMPANOSTOMY TUBE	Acclarent, Inc.	K082188	2008-09-19
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE	Heinz Kurz GmbH Medizintechnik	K071150	2007-12-12
OTOMEDICS SOFT TYMPANOSTOMY TUBE	Otomedics Advanced Medical Technologies, Ltd.	K071178	2007-06-22
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES	Grace Medical, Inc.	K062672	2006-10-24
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES	Grace Medical, Inc.	K062385	2006-09-27
NEOZOLINE VENTILATION TUBES	Adept Medical, Ltd.	K061058	2006-07-12
MICRODOSE CATH, MODELS 90121-201, -202, -203	Durect Corp.	K011383	2001-06-25
PC COATED FLUOROPLASTIC VENT TUBES	Gyrus Ent LLC	K000801	2000-06-19

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