K212728

Substantially Equivalent

Standard Bougie, 38 Fr. and Hand Pump

Applicant: Standard Bariatrics
Product code: KNT
Advisory panel: Gastroenterology, Urology
Date received: 2021-08-27
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

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.