SURGIVISIO Device
K-Number: K221028 · 2022-07-06
ApplicantEcential Robotics
Decision Date2022-07-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SURGIVISIO Device is a medical device manufactured by Ecential Robotics. It received FDA 510(k) clearance on 2022-07-06 under approval number K221028. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SURGIVISIO Device?
SURGIVISIO Device is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Ecential Robotics. The 510(k) number is K221028.
When was SURGIVISIO Device approved by the FDA?
SURGIVISIO Device received FDA 510(k) clearance on 2022-07-06, under approval number K221028.
What company makes SURGIVISIO Device?
SURGIVISIO Device is manufactured by Ecential Robotics.
What is the FDA product code for SURGIVISIO Device?
The FDA product code for SURGIVISIO Device is OLO.
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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.