FDA 510(k)

iMESH Tacker

N.º K: K153202 · 2016-03-24

SolicitanteThd Lap

Fecha de decisión2016-03-24

Código de productoGDW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

iMESH Tacker is the device name listed in this FDA 510(k) record. The listed applicant is Thd Lap. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153202. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the iMESH Tacker?

iMESH Tacker is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Thd Lap. The 510(k) number is K153202.

When did iMESH Tacker receive FDA 510(k) clearance?

iMESH Tacker received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153202.

Who is the listed applicant for iMESH Tacker?

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

What is the FDA product code for iMESH Tacker?

The FDA product code for iMESH Tacker is GDW.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: GDW)

Fuente oficial

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