510(k) K222085

Standard Tapered Bougie, 38 Fr. by Standard Bariatrics, Inc. — Product Code KNT

K222085 is an FDA 510(k) premarket notification submitted by Standard Bariatrics, Inc. for the device "Standard Tapered Bougie, 38 Fr.". The FDA issued a decision of Substantially Equivalent on October 31, 2022. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Standard Bariatrics, Inc. has at least 10 other 510(k) clearances on record.