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FDA 510(k)

GORE SMOOTHER II AND GORE BPTB

K-Number: K941269 · 1994-05-19

ApplicantW. L. Gore & Associates, Inc.
Decision Date1994-05-19
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GORE SMOOTHER II AND GORE BPTB 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 1994-05-19 under 510(k) number K941269. 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 II AND GORE BPTB?

GORE SMOOTHER II AND GORE BPTB is a medical device that received FDA 510(k) clearance on 1994-05-19. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K941269.

When did GORE SMOOTHER II AND GORE BPTB receive FDA 510(k) clearance?

GORE SMOOTHER II AND GORE BPTB received FDA 510(k) clearance on 1994-05-19, under 510(k) number K941269.

Who is the listed applicant for GORE SMOOTHER II AND GORE BPTB?

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 II AND GORE BPTB?

The FDA product code for GORE SMOOTHER II AND GORE BPTB 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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