510(k) K231533

Habib EndoHPB by Boston Scientific Corporation — Product Code KNS

K231533 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Habib EndoHPB". The FDA issued a decision of Substantially Equivalent on June 21, 2023. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.