AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE— 510(k) K973893

Substantially Equivalent

Applied Medical Technologies

FDA 510(k) clearance K973893 for AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE, Substantially Equivalent on 1997-12-19. Applicant: Applied Medical Technologies.

Clearance details

Applicant: Applied Medical Technologies
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1997-10-14
Decision date: 1997-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.