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FDA 510(k)

CORUS Navigation Access System

K-Number: K240625 · 2024-05-03

ApplicantProvidence Medical Technology, Inc.
Decision Date2024-05-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CORUS Navigation Access System is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-05-03 under approval number K240625. 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 CORUS Navigation Access System?

CORUS Navigation Access System is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K240625.

When was CORUS Navigation Access System approved by the FDA?

CORUS Navigation Access System received FDA 510(k) clearance on 2024-05-03, under approval number K240625.

What company makes CORUS Navigation Access System?

CORUS Navigation Access System is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for CORUS Navigation Access System?

The FDA product code for CORUS Navigation Access System is OLO.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT05934487 PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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Related Devices (Code: OLO)

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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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