ONAT BALLOONED NASOGASTRIC TUBE— 510(k) K920262

Substantially Equivalent

Macdonald Medical Devices, Inc.

FDA 510(k) clearance K920262 for ONAT BALLOONED NASOGASTRIC TUBE, Substantially Equivalent on 1993-04-20. Applicant: Macdonald Medical Devices, Inc..

Clearance details

Applicant: Macdonald Medical Devices, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1992-01-21
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheshire, CT, 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.