510(k) K233117

Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) by Nakanishi, Inc. — Product Code EBW

K233117 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)". The FDA issued a decision of Substantially Equivalent on June 20, 2024. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.