PEG GASTROSTOMY TUBE KIT— 510(k) K915308

Unknown

Sandoz Nutrition

FDA 510(k) clearance K915308 for PEG GASTROSTOMY TUBE KIT, Unknown on 1993-03-12. Applicant: Sandoz Nutrition.

Clearance details

Applicant: Sandoz Nutrition
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-21
Decision date: 1993-03-12
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, 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.