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FDA 510(k)

GORE BURR HOLE COVER

K-Number: K960656 · 1996-08-14

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-08-14
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GORE BURR HOLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K960656. 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 GORE BURR HOLE COVER?

GORE BURR HOLE COVER is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K960656.

When did GORE BURR HOLE COVER receive FDA 510(k) clearance?

GORE BURR HOLE COVER received FDA 510(k) clearance on 1996-08-14, under 510(k) number K960656.

Who is the listed applicant for GORE BURR HOLE COVER?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE BURR HOLE COVER?

The FDA product code for GORE BURR HOLE COVER is GXR.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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Related Devices (Code: GXR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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