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FDA 510(k)

PRECLUDE SYNBLOC MEMBRANE

K-Number: K961802 · 1996-07-31

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-07-31
Product CodeGXO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRECLUDE SYNBLOC MEMBRANE 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 1996-07-31 under 510(k) number K961802. The device is classified under product code GXO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECLUDE SYNBLOC MEMBRANE?

PRECLUDE SYNBLOC MEMBRANE is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K961802.

When did PRECLUDE SYNBLOC MEMBRANE receive FDA 510(k) clearance?

PRECLUDE SYNBLOC MEMBRANE received FDA 510(k) clearance on 1996-07-31, under 510(k) number K961802.

Who is the listed applicant for PRECLUDE SYNBLOC MEMBRANE?

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 PRECLUDE SYNBLOC MEMBRANE?

The FDA product code for PRECLUDE SYNBLOC MEMBRANE is GXO.

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

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Related Devices (Code: GXO)

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.

K033395CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1Codman & Shurtleff, Inc.

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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