Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K-Number: K233117 · 2024-06-20
ApplicantNakanishi, Inc.
Decision Date2024-06-20
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2024-06-20 under approval number K233117. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)?
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Nakanishi, Inc.. The 510(k) number is K233117.
When was Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) approved by the FDA?
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) received FDA 510(k) clearance on 2024-06-20, under approval number K233117.
What company makes Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)?
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) is manufactured by Nakanishi, Inc..
What is the FDA product code for Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)?
The FDA product code for Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) is EBW.
Other Devices by Nakanishi, Inc.
Related Devices (Code: EBW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.