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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2024-06-20 under 510(k) 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. The listed applicant is Nakanishi, Inc.. The 510(k) number is K233117.

When did Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) receive FDA 510(k) clearance?

Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233117.

Who is the listed applicant for Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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.

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