Standard Tapered Bougie, 38 Fr.— 510(k) K222085

Name: FDA 510(k) clearance K222085
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Substantially Equivalent

Standard Bariatrics, Inc.

FDA 510(k) clearance K222085 for Standard Tapered Bougie, 38 Fr., Substantially Equivalent on 2022-10-31. Applicant: Standard Bariatrics, Inc.. Device class: 2.

Clearance details

Applicant: Standard Bariatrics, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-15
Decision date: 2022-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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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.