FDA 510(k)

TULA Tube Delivery System

Número K: K171239 · 2017-06-28

Data da decisão2017-06-28

Código do produtoETD

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

TULA Tube Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Tusker Medical. It received FDA 510(k) clearance on 2017-06-28 under 510(k) number K171239. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TULA Tube Delivery System?

TULA Tube Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-28. The listed applicant is Tusker Medical. The 510(k) number is K171239.

When did TULA Tube Delivery System receive FDA 510(k) clearance?

TULA Tube Delivery System received FDA 510(k) clearance on 2017-06-28, under 510(k) number K171239.

Who is the listed applicant for TULA Tube Delivery System?

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

What is the FDA product code for TULA Tube Delivery System?

The FDA product code for TULA Tube Delivery System is ETD.

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Dispositivos Relacionados (Código: ETD)

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.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.

Fonte oficial

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