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FDA 510(k)

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES

K-Number: K023949 · 2003-02-25

ApplicantImage-Guided Neurologics, Inc.
Decision Date2003-02-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES is the device name listed in this FDA 510(k) record. The listed applicant is Image-Guided Neurologics, Inc.. It received FDA 510(k) clearance on 2003-02-25 under 510(k) number K023949. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES?

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES is a medical device that received FDA 510(k) clearance on 2003-02-25. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K023949.

When did NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES receive FDA 510(k) clearance?

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES received FDA 510(k) clearance on 2003-02-25, under 510(k) number K023949.

Who is the listed applicant for NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES?

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

What is the FDA product code for NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES?

The FDA product code for NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES is HAW.

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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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