FDA 510(k)

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

K-Number: K181940 · 2018-08-17

Decision Date2018-08-17

Product CodeOXC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement 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 2018-08-17 under 510(k) number K181940. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K181940.

When did GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement receive FDA 510(k) clearance?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181940.

Who is the listed applicant for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

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 SEAMGUARD Bioabsorbable Staple Line Reinforcement?

The FDA product code for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is OXC.

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

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Related Devices (Code: OXC)

K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC K221487NEOVEIL Staple Line ReinforcementGunze Limited K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC

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.