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FDA 510(k)

Phoenix Sinus Tarsi Stent System

K-Number: K251382 · 2025-08-27

ApplicantAstra Orthomed, Inc.
Decision Date2025-08-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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