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FDA 510(k)

BURR HOLE COVER, MODEL XX

K-Number: K001096 · 2000-10-25

ApplicantImage-Guided Neurologics, Inc.
Decision Date2000-10-25
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BURR HOLE COVER, MODEL XX 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 2000-10-25 under 510(k) number K001096. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURR HOLE COVER, MODEL XX?

BURR HOLE COVER, MODEL XX is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K001096.

When did BURR HOLE COVER, MODEL XX receive FDA 510(k) clearance?

BURR HOLE COVER, MODEL XX received FDA 510(k) clearance on 2000-10-25, under 510(k) number K001096.

Who is the listed applicant for BURR HOLE COVER, MODEL XX?

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 BURR HOLE COVER, MODEL XX?

The FDA product code for BURR HOLE COVER, MODEL XX is GXR.

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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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