Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

K-Number: K181940 · 2018-08-17

ApplicantW. L. Gore & Associates, Inc.
Decision Date2018-08-17
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement approved by the FDA?

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

What company makes GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is manufactured by W. L. Gore & Associates, Inc..

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.

Related Clinical Trials

NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy COMPLETED

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

K160254GORE DrySeal Flex Introducer Sheath K163576GORE SYNECOR Preperitoneal Biomaterial K170740GORE VIABIL Short Wire Biliary Endoprosthesis K163217GORE BIO-A Tissue Reinforcement K173333GORE ENFORM Biomaterial K191773GORE BIO-A Tissue Reinforcement

View all 24 devices →

Related Devices (Code: OXC)

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

↑