Synthecure Synthetic Calcium Sulfate
K-Number: K250141 · 2025-05-16
ApplicantAustin Medical Ventures, Inc.
Decision Date2025-05-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Synthecure Synthetic Calcium Sulfate is a medical device manufactured by Austin Medical Ventures, Inc.. It received FDA 510(k) clearance on 2025-05-16 under approval number K250141. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synthecure Synthetic Calcium Sulfate?
Synthecure Synthetic Calcium Sulfate is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Austin Medical Ventures, Inc.. The 510(k) number is K250141.
When was Synthecure Synthetic Calcium Sulfate approved by the FDA?
Synthecure Synthetic Calcium Sulfate received FDA 510(k) clearance on 2025-05-16, under approval number K250141.
What company makes Synthecure Synthetic Calcium Sulfate?
Synthecure Synthetic Calcium Sulfate is manufactured by Austin Medical Ventures, Inc..
What is the FDA product code for Synthecure Synthetic Calcium Sulfate?
The FDA product code for Synthecure Synthetic Calcium Sulfate is MQV.
Related Clinical Trials
Related Devices (Code: MQV)
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.