Curajel Oral Gel— 510(k) K260126

Substantially Equivalent

USpharma, Ltd.

FDA 510(k) clearance K260126 for Curajel Oral Gel, Substantially Equivalent on 2026-06-15. Applicant: USpharma, Ltd..

Clearance details

Applicant: USpharma, Ltd.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2026-01-15
Decision date: 2026-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.