DeviceClearance

Nasal Pancreatic Drainage Set— 510(k) K171623

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K171623 for Nasal Pancreatic Drainage Set, Substantially Equivalent on 2017-07-31. Applicant: Cook Ireland, Ltd.. Device class: 2.

Clearance details

Applicant
Cook Ireland, Ltd.
Product code
Code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Limerick, IE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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.