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FDA 510(k)

Elemental Granulate

K-Number: K241283 · 2025-01-03

ApplicantZinkh NV
Decision Date2025-01-03
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Elemental Granulate is a medical device manufactured by Zinkh NV. It received FDA 510(k) clearance on 2025-01-03 under approval number K241283. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elemental Granulate?

Elemental Granulate is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Zinkh NV. The 510(k) number is K241283.

When was Elemental Granulate approved by the FDA?

Elemental Granulate received FDA 510(k) clearance on 2025-01-03, under approval number K241283.

What company makes Elemental Granulate?

Elemental Granulate is manufactured by Zinkh NV.

What is the FDA product code for Elemental Granulate?

The FDA product code for Elemental Granulate is OLR.

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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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