ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE— 510(k) K901134

Unknown

Fresenius Pharma

FDA 510(k) clearance K901134 for ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE, Unknown on 1990-06-20. Applicant: Fresenius Pharma.

Clearance details

Applicant: Fresenius Pharma
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-12
Decision date: 1990-06-20
Decision: Unknown
Clearance type: Traditional
Location: New Brunswick, NJ, 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.