COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)— 510(k) K965087

Unknown

Sandoz Nutrition

FDA 510(k) clearance K965087 for COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000), Unknown on 1997-03-18. Applicant: Sandoz Nutrition.

Clearance details

Applicant: Sandoz Nutrition
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-19
Decision date: 1997-03-18
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, MN, US

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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, 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.