NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT— 510(k) K071191

Substantially Equivalent

Novartis Nutrition Corp.

FDA 510(k) clearance K071191 for NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT, Substantially Equivalent on 2007-07-23. Applicant: Novartis Nutrition Corp..

Clearance details

Applicant: Novartis Nutrition Corp.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-30
Decision date: 2007-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis Park, MN, US

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.