GASTROINTESTINAL TUBE AND ACCESSORIES— 510(k) K914492

Name: FDA 510(k) clearance K914492
Creator: U.S. Food and Drug Administration
Published: 1992-02-25

Unknown

Sandoz Nutrition

FDA 510(k) clearance K914492 for GASTROINTESTINAL TUBE AND ACCESSORIES, Unknown on 1992-02-25. Applicant: Sandoz Nutrition. Device class: 2.

Clearance details

Applicant: Sandoz Nutrition
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-08
Decision date: 1992-02-25
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K965087 — COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)1997-03-18
K961664 — COMPAT NASOJEJUNAL FEEDING TUBE1996-10-04
K940555 — SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION1995-02-01
K940556 — SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP1994-11-07
K924308 — GASTROPORT II1993-07-29

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.