COMPAT ENTERAL DELIVERY SYSTEMS— 510(k) K855097

Substantially Equivalent

Sandoz Nutrition

FDA 510(k) clearance K855097 for COMPAT ENTERAL DELIVERY SYSTEMS, Substantially Equivalent on 1986-04-08. Applicant: Sandoz Nutrition.

Clearance details

Applicant: Sandoz Nutrition
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-23
Decision date: 1986-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.