FDA 510(k)

Tula Tympanostomy Tube Delivery Device

N.º K: K252436 · 2026-04-23

Fecha de decisión2026-04-23

Código de productoETD

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tula Tympanostomy Tube Delivery Device is the device name listed in this FDA 510(k) record. The listed applicant is Tusker Medical, Inc.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K252436. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tula Tympanostomy Tube Delivery Device?

Tula Tympanostomy Tube Delivery Device is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Tusker Medical, Inc.. The 510(k) number is K252436.

When did Tula Tympanostomy Tube Delivery Device receive FDA 510(k) clearance?

Tula Tympanostomy Tube Delivery Device received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252436.

Who is the listed applicant for Tula Tympanostomy Tube Delivery Device?

The FDA 510(k) record lists Tusker Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tula Tympanostomy Tube Delivery Device?

The FDA product code for Tula Tympanostomy Tube Delivery Device is ETD.

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Dispositivos relacionados (Código: ETD)

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 Dac K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac K233658Biowy Tym Tube (TT)Biowy Corporation K232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.

Fuente oficial

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