AQUARIUS Gastrostomy Replacement Tube— 510(k) K143378

Name: FDA 510(k) clearance K143378
Creator: U.S. Food and Drug Administration
Published: 2014-12-29

Substantially Equivalent

Degania Silicone , Ltd.

FDA 510(k) clearance K143378 for AQUARIUS Gastrostomy Replacement Tube, Substantially Equivalent on 2014-12-29. Applicant: Degania Silicone , Ltd.. Device class: 2.

Clearance details

Applicant: Degania Silicone , Ltd.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2014-11-25
Decision date: 2014-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Degania Bet, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.