KleenGel Dispenser— 510(k) K143177

Substantially Equivalent

Kleengel, LLC

FDA 510(k) clearance K143177 for KleenGel Dispenser, Substantially Equivalent on 2015-09-14. Applicant: Kleengel, LLC.

Clearance details

Applicant: Kleengel, LLC
Product code: Code KYX
Advisory panel: General Hospital
Date received: 2014-11-04
Decision date: 2015-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

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.