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FDA 510(k)

SURGIVISIO Device

K-Number: K231886 · 2023-07-27

Decision Date2023-07-27
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 2023-07-27 under approval number K231886. 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 2023-07-27. It is manufactured by Ecential Robotics. The 510(k) number is K231886.

When was SURGIVISIO Device approved by the FDA?

SURGIVISIO Device received FDA 510(k) clearance on 2023-07-27, under approval number K231886.

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.

Other Devices by Ecential Robotics

Related Devices (Code: OLO)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.