FDA 510(k)

Elemental Granulate

K-Number: K241283 · 2025-01-03

Decision Date2025-01-03

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

Elemental Granulate is the device name listed in this FDA 510(k) record. The listed applicant is Zinkh NV. It received FDA 510(k) clearance on 2025-01-03 under 510(k) 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. The listed applicant is Zinkh NV. The 510(k) number is K241283.

When did Elemental Granulate receive FDA 510(k) clearance?

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

Who is the listed applicant for Elemental Granulate?

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

What is the FDA product code for Elemental Granulate?

The FDA product code for Elemental Granulate is OLR.

Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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.