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FDA 510(k)

Curiteva Navigation System

K-Number: K223200 · 2023-01-06

ApplicantCuriteva, Inc.
Decision Date2023-01-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Curiteva Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K223200. 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 Curiteva Navigation System?

Curiteva Navigation System is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Curiteva, Inc.. The 510(k) number is K223200.

When did Curiteva Navigation System receive FDA 510(k) clearance?

Curiteva Navigation System received FDA 510(k) clearance on 2023-01-06, under 510(k) number K223200.

Who is the listed applicant for Curiteva Navigation System?

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

What is the FDA product code for Curiteva Navigation System?

The FDA product code for Curiteva Navigation System is OLO.

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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.

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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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