VINYL BAG W/PUMP ADMINISTRATION SET— 510(k) K893540

Name: FDA 510(k) clearance K893540
Creator: U.S. Food and Drug Administration
Published: 1989-10-17

Substantially Equivalent

Sandoz Nutrition

FDA 510(k) clearance K893540 for VINYL BAG W/PUMP ADMINISTRATION SET, Substantially Equivalent on 1989-10-17. Applicant: Sandoz Nutrition. Device class: 2.

Clearance details

Applicant: Sandoz Nutrition
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-05-08
Decision date: 1989-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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 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.