FDA 510(k) Applications for Medical Device Product Code "OXC"

FDA 510(k) Number Applicant Device Name Decision Date
K190937 Ethicon Endo-Surgery LLC Echelon Endopath Staple Line Reinforcement 10/14/2019
K221343 Ethicon Endo-Surgery LLC ECHELON ENDOPATH Staple Line Reinforcement 09/16/2022
K130997 GUNZE LIMITED NEOVEIL 11/15/2013
K221487 Gunze Limited NEOVEIL Staple Line Reinforcement 08/26/2022
K231603 Standard Bariatrics, Inc. Standard Staple-Line Reinforcement (SSLR23) 10/06/2023
K181940 W. L. Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement 08/17/2018
K150551 W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD Reinforcement 03/30/2015
K131658 W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD REINFORCEMENT 09/06/2013


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