KleenGel Dispenser— 510(k) K143177

Name: FDA 510(k) clearance K143177
Creator: U.S. Food and Drug Administration
Published: 2015-09-14

Substantially Equivalent

Kleengel, LLC

FDA 510(k) clearance K143177 for KleenGel Dispenser, Substantially Equivalent on 2015-09-14. Applicant: Kleengel, LLC. Device class: 1.

Clearance details

Applicant: Kleengel, LLC
Product code: Code KYX
Device class: Class 1
Regulation: 21 CFR 880.6430
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 ↗

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K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER1998-08-18
K954181 — CANYONS BI-DIRECTIONAL CHECK VALVE1995-11-29
K830571 — BOTTLE ADAPTER1983-03-24
K801008 — MULTI-AD FLUID DISPENSING PUMP MP-30001980-06-02
K800362 — FLUID DISPENSING SYSTEM1980-03-12

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.