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FDA 510(k)

superDimension Navigation System V7.2

K-Number: K173244 · 2018-02-08

ApplicantCovidien, LLC
Decision Date2018-02-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

superDimension Navigation System V7.2 is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2018-02-08 under approval number K173244. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the superDimension Navigation System V7.2?

superDimension Navigation System V7.2 is a medical device that received FDA 510(k) clearance on 2018-02-08. It is manufactured by Covidien, LLC. The 510(k) number is K173244.

When was superDimension Navigation System V7.2 approved by the FDA?

superDimension Navigation System V7.2 received FDA 510(k) clearance on 2018-02-08, under approval number K173244.

What company makes superDimension Navigation System V7.2?

superDimension Navigation System V7.2 is manufactured by Covidien, LLC.

What is the FDA product code for superDimension Navigation System V7.2?

The FDA product code for superDimension Navigation System V7.2 is JAK.

Related Clinical Trials

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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)

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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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