gel-e Flex+ gel OTC— 510(k) K192667

Substantially Equivalent

Gel-E, Inc.

FDA 510(k) clearance K192667 for gel-e Flex+ gel OTC, Substantially Equivalent on 2019-10-25. Applicant: Gel-E, Inc..

Clearance details

Applicant: Gel-E, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2019-09-25
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: College Park, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.