FDA 510(k) Applications Submitted by Apollo Endosurgery, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
DEN210045 09/30/2021 APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System Apollo Endosurgery, Inc.
K081853 06/30/2008 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM APOLLO ENDOSURGERY, INC.
K082102 07/25/2008 GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 APOLLO ENDOSURGERY, INC.
K082114 07/28/2008 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 APOLLO ENDOSURGERY, INC.
K090583 03/04/2009 ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 APOLLO ENDOSURGERY, INC.
K103155 10/26/2010 SUMO ACCESS AND TISSUE RESECTION SYSTEM APOLLO ENDOSURGERY, INC.
K122270 07/30/2012 OVERTUBE ENDOSCOPIC ACCESS SYSTEM APOLLO ENDOSURGERY, INC.
K201808 07/01/2020 X-Tack Endoscopic HeliX Tacking System Apollo Endosurgery, Inc.


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