FDA 510(k) Applications Submitted by W. L. GORE & ASSOCIATES, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K070770 03/20/2007 GORE BALLOON SHEATH W. L. GORE & ASSOCIATES, INC.
K082356 08/18/2008 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. GORE & ASSOCIATES, INC.
K121234 04/24/2012 GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING W. L. GORE & ASSOCIATES, INC.
K070644 03/08/2007 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. GORE & ASSOCIATES, INC.
K131658 06/06/2013 GORE SEAMGUARD REINFORCEMENT W. L. GORE & ASSOCIATES, INC.
K163217 11/16/2016 GORE BIO-A Tissue Reinforcement W. L. GORE & ASSOCIATES, INC.
K132397 08/01/2013 GORE BIO-A WOUND MATRIX W. L. GORE & ASSOCIATES, INC.
K150551 03/04/2015 GORE SEAMGUARD Reinforcement W. L. GORE & ASSOCIATES, INC.
K032073 07/03/2003 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. GORE & ASSOCIATES, INC.
K032168 07/16/2003 GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC.
K033670 11/24/2003 GORE TRI-LOBE BALLOON CATHETER W. L. GORE & ASSOCIATES, INC.
K033671 11/24/2003 GORE BIOABSORBABLE MESH W. L. GORE & ASSOCIATES, INC.
K081799 06/25/2008 GORE TRI-LOBE BALLOON CATHETER W. L. GORE & ASSOCIATES, INC.
K041423 05/28/2004 VIABIL BILIARY ENDOPROSTHESIS W. L. GORE & ASSOCIATES, INC.
K043081 11/08/2004 GORE POLYPROPYLENE HERNIA MESH W. L. GORE & ASSOCIATES, INC.
K063435 11/13/2006 GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC.
K181940 07/19/2018 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc.
K163576 12/19/2016 GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc.
K030782 03/11/2003 SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. GORE & ASSOCIATES, INC.
K032865 09/12/2003 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. GORE & ASSOCIATES, INC.
K120428 02/13/2012 GORE DRYSEAL SHEATH W. L. GORE & ASSOCIATES, INC.
K013282 10/02/2001 GORE INTRODUCER SHEATH W. L. GORE & ASSOCIATES, INC.
K231505 05/24/2023 GORE« ACUSEAL Vascular Graft W. L. Gore & Associates, Inc.
K123156 10/09/2012 GORE FLOW REVERSAL SYSTEM MODEL GFRS073 W. L. GORE & ASSOCIATES, INC.
K021477 05/08/2002 PRECLUDE MVP DURA SUBSTITUTE W. L. GORE & ASSOCIATES, INC.
K013250 09/28/2001 GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. GORE & ASSOCIATES, INC.


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