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FDA 510(k)

Xerosyn

K-Number: K233259 · 2024-06-21

ApplicantXerothera, Inc.
Decision Date2024-06-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xerosyn is the device name listed in this FDA 510(k) record. The listed applicant is Xerothera, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233259. 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 Xerosyn?

Xerosyn is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Xerothera, Inc.. The 510(k) number is K233259.

When did Xerosyn receive FDA 510(k) clearance?

Xerosyn received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233259.

Who is the listed applicant for Xerosyn?

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

What is the FDA product code for Xerosyn?

The FDA product code for Xerosyn is MQV.

Related Devices (Code: MQV)

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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