FDA 510(k) Applications Submitted by Steve Hoffman

FDA 510(k) Number Submission Date Device Name Applicant
K171307 05/03/2017 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories EndoGastric Solutions, Inc.
K091832 06/22/2009 ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER ENDOGASTRIC SOLUTIONS, INC.
K092400 08/06/2009 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 ENDOGASTRIC SOLUTIONS, INC.
K172811 09/18/2017 EsophyX Z, EsophyX2 HD EndoGastric Solutions, Inc.
K160960 04/05/2016 EsophyX« Z Device with SerosaFuse Fasteners and Accessories ENDOGASTRIC SOLUTIONS, INC.
K062875 09/26/2006 ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC.


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