FDA 510(k)

Phoenix Sinus Tarsi Stent System

N.º K: K251382 · 2025-08-27

Fecha de decisión2025-08-27

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Phoenix Sinus Tarsi Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Astra Orthomed, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251382. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Phoenix Sinus Tarsi Stent System?

Phoenix Sinus Tarsi Stent System is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Astra Orthomed, Inc.. The 510(k) number is K251382.

When did Phoenix Sinus Tarsi Stent System receive FDA 510(k) clearance?

Phoenix Sinus Tarsi Stent System received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251382.

Who is the listed applicant for Phoenix Sinus Tarsi Stent System?

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

What is the FDA product code for Phoenix Sinus Tarsi Stent System?

The FDA product code for Phoenix Sinus Tarsi Stent System is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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