Standard Bougie— 510(k) K191885

Substantially Equivalent

Standard Bariatrics

FDA 510(k) clearance K191885 for Standard Bougie, Substantially Equivalent on 2020-04-08. Applicant: Standard Bariatrics.

Clearance details

Applicant: Standard Bariatrics
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-15
Decision date: 2020-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.