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FDA 510(k)

Medyssey Navigation System

K-Number: K242806 · 2025-04-16

ApplicantMedyssey Co, Ltd.
Decision Date2025-04-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Medyssey Navigation System is a medical device manufactured by Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under approval number K242806. 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 Medyssey Navigation System?

Medyssey Navigation System is a medical device that received FDA 510(k) clearance on 2025-04-16. It is manufactured by Medyssey Co, Ltd.. The 510(k) number is K242806.

When was Medyssey Navigation System approved by the FDA?

Medyssey Navigation System received FDA 510(k) clearance on 2025-04-16, under approval number K242806.

What company makes Medyssey Navigation System?

Medyssey Navigation System is manufactured by Medyssey Co, Ltd..

What is the FDA product code for Medyssey Navigation System?

The FDA product code for Medyssey Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

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)

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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