RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT— 510(k) K972102

Substantially Equivalent

Radius Intl., Inc.

FDA 510(k) clearance K972102 for RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT, Substantially Equivalent on 1998-01-23. Applicant: Radius Intl., Inc..

Clearance details

Applicant: Radius Intl., Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1997-06-04
Decision date: 1998-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarpon Springs, FL, 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.