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FDA 510(k)

Surgivisio system

K-Number: K202547 · 2021-03-26

ApplicantSurgivisio
Decision Date2021-03-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Surgivisio system is a medical device manufactured by Surgivisio. It received FDA 510(k) clearance on 2021-03-26 under approval number K202547. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgivisio system?

Surgivisio system is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Surgivisio. The 510(k) number is K202547.

When was Surgivisio system approved by the FDA?

Surgivisio system received FDA 510(k) clearance on 2021-03-26, under approval number K202547.

What company makes Surgivisio system?

Surgivisio system is manufactured by Surgivisio.

What is the FDA product code for Surgivisio system?

The FDA product code for Surgivisio system is OWB.

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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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