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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2022-07-06 under 510(k) 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. The listed applicant is Ecential Robotics. The 510(k) number is K221028.

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

SURGIVISIO Device received FDA 510(k) clearance on 2022-07-06, under 510(k) number K221028.

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 OLO.

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.

K261113Op.n™ Spine Navigation and Robotic GuidanceK242914Op.n(TM) NavigationK233228Spine Navigation and Robotic-Assistance DeviceK231886SURGIVISIO DeviceK220946SURGIVISIO DeviceK220627SURGIVISIO Device

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Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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