510(k) K212728

Standard Bougie, 38 Fr. and Hand Pump by Standard Bariatrics — Product Code KNT

K212728 is an FDA 510(k) premarket notification submitted by Standard Bariatrics for the device "Standard Bougie, 38 Fr. and Hand Pump". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Standard Bariatrics has at least 10 other 510(k) clearances on record.