
Standard Bariatrics
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Standard Bougie, 38 Fr. is an FDA 510(k)-cleared medical device (K210437) manufactured by Standard Bariatrics. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2021. Regulation: 8.