GORE BIO-A Tissue Reinforcement
K-Number: K191773 · 2019-07-31
ApplicantW. L. Gore & Associates, Inc.
Decision Date2019-07-31
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
GORE BIO-A Tissue Reinforcement is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2019-07-31 under approval number K191773. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GORE BIO-A Tissue Reinforcement?
GORE BIO-A Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K191773.
When was GORE BIO-A Tissue Reinforcement approved by the FDA?
GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance on 2019-07-31, under approval number K191773.
What company makes GORE BIO-A Tissue Reinforcement?
GORE BIO-A Tissue Reinforcement is manufactured by W. L. Gore & Associates, Inc..
What is the FDA product code for GORE BIO-A Tissue Reinforcement?
The FDA product code for GORE BIO-A Tissue Reinforcement is OWT.
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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.