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FDA 510(k)

GORE SMOOTHER GUIDED RASP

K-Number: K951163 · 1995-06-01

ApplicantW. L. Gore & Associates, Inc.
Decision Date1995-06-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GORE SMOOTHER GUIDED RASP 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 1995-06-01 under 510(k) number K951163. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE SMOOTHER GUIDED RASP?

GORE SMOOTHER GUIDED RASP is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K951163.

When did GORE SMOOTHER GUIDED RASP receive FDA 510(k) clearance?

GORE SMOOTHER GUIDED RASP received FDA 510(k) clearance on 1995-06-01, under 510(k) number K951163.

Who is the listed applicant for GORE SMOOTHER GUIDED RASP?

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 SMOOTHER GUIDED RASP?

The FDA product code for GORE SMOOTHER GUIDED RASP is HRX.

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

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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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