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FDA 510(k)

SurgiCube

K-Number: K163455 · 2017-09-28

ApplicantSurgicube International B.V.
Decision Date2017-09-28
Product CodeORC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurgiCube is the device name listed in this FDA 510(k) record. The listed applicant is Surgicube International B.V.. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K163455. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiCube?

SurgiCube is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Surgicube International B.V.. The 510(k) number is K163455.

When did SurgiCube receive FDA 510(k) clearance?

SurgiCube received FDA 510(k) clearance on 2017-09-28, under 510(k) number K163455.

Who is the listed applicant for SurgiCube?

The FDA 510(k) record lists Surgicube International B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiCube?

The FDA product code for SurgiCube is ORC.

Related Devices (Code: ORC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190027SteriStayToul Meditech ABK173349OperioToul Meditech ABK153498OperioToul Meditech AB

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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