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FDA 510(k)

SURGIVISIO Device

K-Number: K220627 · 2022-03-18

ApplicantEcential Robotics
Decision Date2022-03-18
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGIVISIO Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K220627. 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 Device?

SURGIVISIO Device is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Ecential Robotics. The 510(k) number is K220627.

When did SURGIVISIO Device receive FDA 510(k) clearance?

SURGIVISIO Device received FDA 510(k) clearance on 2022-03-18, under 510(k) number K220627.

Who is the listed applicant for SURGIVISIO Device?

The FDA 510(k) record lists Ecential Robotics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIVISIO Device?

The FDA product code for SURGIVISIO Device is OWB.

Other records listing Ecential Robotics as applicant

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.

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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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