GELX ORAL GEL— 510(k) K081372

Substantially Equivalent

Bmg Pharma, LLC

FDA 510(k) clearance K081372 for GELX ORAL GEL, Substantially Equivalent on 2009-02-04. Applicant: Bmg Pharma, LLC.

Clearance details

Applicant: Bmg Pharma, LLC
Product code: Code OLR
Advisory panel: Unknown
Date received: 2008-05-16
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardnerville, NV, 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.