FDA 510(k)

Curajel™ Oral Gel

K-Number: K260126 · 2026-06-15

Decision Date2026-06-15

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

Curajel™ Oral Gel is the device name listed in this FDA 510(k) record. The listed applicant is USpharma, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260126. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curajel™ Oral Gel?

Curajel™ Oral Gel is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is USpharma, Ltd.. The 510(k) number is K260126.

When did Curajel™ Oral Gel receive FDA 510(k) clearance?

Curajel™ Oral Gel received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260126.

Who is the listed applicant for Curajel™ Oral Gel?

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

What is the FDA product code for Curajel™ Oral Gel?

The FDA product code for Curajel™ Oral Gel 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 K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC K241283Elemental GranulateZinkh NV

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.