510(k) K190621

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long by Sumitomo Bakelite Co., Ltd. — Product Code KNS

K190621 is an FDA 510(k) premarket notification submitted by Sumitomo Bakelite Co., Ltd. for the device "SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long". The FDA issued a decision of Substantially Equivalent on Apr 23, 2019. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Sumitomo Bakelite Co., Ltd. has 3 other 510(k) clearances on record.