gel-e Flex— 510(k) K180152

Name: FDA 510(k) clearance K180152
Creator: U.S. Food and Drug Administration
Published: 2018-06-22

Substantially Equivalent

Gel-E, Inc.

FDA 510(k) clearance K180152 for gel-e Flex, Substantially Equivalent on 2018-06-22. Applicant: Gel-E, Inc.. Device class: Unclassified.

Clearance details

Applicant: Gel-E, Inc.
Product code: Product code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-01-19
Decision date: 2018-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: College Park, MD, US

Download summary PDF View on FDA.gov ↗

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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.