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FDA 510(k)

GORE SYNECOR Preperitoneal Biomaterial

K-Number: K163576 · 2017-05-11

ApplicantW. L. Gore & Associates, Inc.
Decision Date2017-05-11
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE SYNECOR Preperitoneal Biomaterial is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2017-05-11 under approval number K163576. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE SYNECOR Preperitoneal Biomaterial?

GORE SYNECOR Preperitoneal Biomaterial is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K163576.

When was GORE SYNECOR Preperitoneal Biomaterial approved by the FDA?

GORE SYNECOR Preperitoneal Biomaterial received FDA 510(k) clearance on 2017-05-11, under approval number K163576.

What company makes GORE SYNECOR Preperitoneal Biomaterial?

GORE SYNECOR Preperitoneal Biomaterial is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE SYNECOR Preperitoneal Biomaterial?

The FDA product code for GORE SYNECOR Preperitoneal Biomaterial is FTL.

Other Devices by W. L. Gore & Associates, Inc.

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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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