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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Austin Medical Ventures, Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) 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. The listed applicant is Austin Medical Ventures, Inc.. The 510(k) number is K250141.

When did Synthecure Synthetic Calcium Sulfate receive FDA 510(k) clearance?

Synthecure Synthetic Calcium Sulfate received FDA 510(k) clearance on 2025-05-16, under 510(k) number K250141.

Who is the listed applicant for Synthecure Synthetic Calcium Sulfate?

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

What is the FDA product code for Synthecure Synthetic Calcium Sulfate?

The FDA product code for Synthecure Synthetic Calcium Sulfate is MQV.

Related Devices (Code: MQV)

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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.

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