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FDA 510(k)

NAVIGUS PEEL AWAY INTRODUCER

K-Number: K002330 · 2000-10-18

ApplicantImage-Guided Neurologics, Inc.
Decision Date2000-10-18
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGUS PEEL AWAY INTRODUCER 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 2000-10-18 under 510(k) number K002330. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGUS PEEL AWAY INTRODUCER?

NAVIGUS PEEL AWAY INTRODUCER is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K002330.

When did NAVIGUS PEEL AWAY INTRODUCER receive FDA 510(k) clearance?

NAVIGUS PEEL AWAY INTRODUCER received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002330.

Who is the listed applicant for NAVIGUS PEEL AWAY INTRODUCER?

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 PEEL AWAY INTRODUCER?

The FDA product code for NAVIGUS PEEL AWAY INTRODUCER is GWG.

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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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