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FDA 510(k)

Device 300423 Granules

K-Number: K251556 · 2025-07-17

ApplicantGeistlich Pharma AG
Decision Date2025-07-17
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Device 300423 Granules is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K251556. 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 Device 300423 Granules?

Device 300423 Granules is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251556.

When did Device 300423 Granules receive FDA 510(k) clearance?

Device 300423 Granules received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251556.

Who is the listed applicant for Device 300423 Granules?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Device 300423 Granules?

The FDA product code for Device 300423 Granules is MQV.

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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

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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