510(k) K233113

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) by Starmed Co., Ltd. — Product Code KNS

K233113 is an FDA 510(k) premarket notification submitted by Starmed Co., Ltd. for the device "ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)". The FDA issued a decision of Substantially Equivalent on October 25, 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. Starmed Co., Ltd. has at least 10 other 510(k) clearances on record.