FDA.reportPublic FDA data

510(k) K252436

Device
Tula Tympanostomy Tube Delivery Device
Applicant
Tusker Medical, Inc.
510(k) number
K252436
Product code
ETD
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-23
Date received
2025-08-01
Regulation
874.3880
Classification name
Tube, Tympanostomy
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Nan McIntosh
Address
7000 W. William Cannon Dr., Suite.110 Austin TX US 78735 78735

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250256Solo+ 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 Dac2025-04-28
K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac2024-05-20
K233658Biowy Tym Tube (TT)Biowy Corporation2024-02-16
K232059Tympanostomy TubesGrace Medical, Inc.2023-11-24
K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.2022-07-27
K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.2020-06-05
K171239TULA Tube Delivery SystemTusker Medical2017-06-28
K151830Hummingbird Tympanostomy TubePreceptis Medical2015-09-21
K151067Ventilation (Tympanostomy) TubesMedtronic Xomed, Inc.2015-07-22
K142282HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)Preceptis Medical2015-04-23
K133921PRECEPTIS TYMPANOSTOMY TUBE INSERTERPreceptis Medical2014-08-22
K103595ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEMAcclarent, Inc.2011-04-01
K082188TYMPANOSTOMY TUBEAcclarent, Inc.2008-09-19
K071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIREHeinz Kurz GmbH Medizintechnik2007-12-12
K071178OTOMEDICS SOFT TYMPANOSTOMY TUBEOtomedics Advanced Medical Technologies, Ltd.2007-06-22