
Standard Bariatrics, Inc.
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Standard Tapered Bougie, 38 Fr. is an FDA 510(k)-cleared medical device (K222085) manufactured by Standard Bariatrics, Inc.. 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 October 30, 2022. Regulation: 8.