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 a medical device manufactured by Surgicube International B.V.. It received FDA 510(k) clearance on 2017-09-28 under approval 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. It is manufactured by Surgicube International B.V.. The 510(k) number is K163455.
When was SurgiCube approved by the FDA?
SurgiCube received FDA 510(k) clearance on 2017-09-28, under approval number K163455.
What company makes SurgiCube?
SurgiCube is manufactured by Surgicube International B.V..
What is the FDA product code for SurgiCube?
The FDA product code for SurgiCube is ORC.
Related Devices (Code: ORC)
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.