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 a medical device manufactured by Astra Orthomed, Inc.. It received FDA 510(k) clearance on 2025-08-27 under approval 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. It is manufactured by Astra Orthomed, Inc.. The 510(k) number is K251382.
When was Phoenix Sinus Tarsi Stent System approved by the FDA?
Phoenix Sinus Tarsi Stent System received FDA 510(k) clearance on 2025-08-27, under approval number K251382.
What company makes Phoenix Sinus Tarsi Stent System?
Phoenix Sinus Tarsi Stent System is manufactured by Astra Orthomed, Inc..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.