AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE— 510(k) K132686

Unknown

Degania Silicone , Ltd.

FDA 510(k) clearance K132686 for AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE, Unknown on 2014-05-12. Applicant: Degania Silicone , Ltd..

Clearance details

Applicant
Degania Silicone , Ltd.
Product code
Code KNT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Emek Hayarden, IL
Download summary PDFView on FDA.gov ↗

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, through . 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.