Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes— 510(k) K181787

Substantially Equivalent

Cedic S.R.L.

FDA 510(k) clearance K181787 for Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes, Substantially Equivalent on 2019-04-25. Applicant: Cedic S.R.L.. Device class: 2.

Clearance details

Applicant
Cedic S.R.L.
Product code
Code PIF
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Peschiera Borromeo, IT
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PIF

product code PIF
Death
13
Injury
122
Other
1
Total
136

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.