510(k) K153358

Standard Clamp by Standard Bariatrics — Product Code GDJ

K153358 is an FDA 510(k) premarket notification submitted by Standard Bariatrics for the device "Standard Clamp". The FDA issued a decision of Substantially Equivalent on May 2, 2016. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Standard Bariatrics has at least 10 other 510(k) clearances on record.