ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE— 510(k) K904801

Substantially Equivalent

Orion Life Systems, Inc.

FDA 510(k) clearance K904801 for ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE, Substantially Equivalent on 1991-01-16. Applicant: Orion Life Systems, Inc..

Clearance details

Applicant: Orion Life Systems, Inc.
Product code: Code KGC
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-24
Decision date: 1991-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

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Adverse events under product code KGC

product code KGC

Death: 7
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.