FDA 510(k) Applications Submitted by TransEnterix, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K102646 09/14/2010 SPIDER FLEX MONOPOLAR HOOK TRANSENTERIX, INC.
K102839 09/29/2010 SPIDER STANDARD AND ADVANCED TRANSENTERIX, INC.
K200049 01/09/2020 Senhance Surgical System TransEnterix, Inc.
K181517 06/08/2018 Senhance Surgical System TransEnterix, Inc.
K202166 08/03/2020 Senhance Surgical System TransEnterix, Inc.
K192877 10/08/2019 Senhance Surgical System TransEnterix, Inc.
K183098 11/07/2018 Senhance Surgical System TransEnterix, Inc.
K180163 01/19/2018 TransEnterix Senhance Surgical System TransEnterix, Inc.
K171120 04/14/2017 Senhance Surgical Robotic System TransEnterix, Inc.
K182421 09/05/2018 Senhance Ultrasonic System TransEnterix, Inc.
K090902 04/01/2009 SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 TRANSENTERIX, INC.
K091697 06/10/2009 SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 TRANSENTERIX, INC.
K120403 02/09/2012 SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER TRANSENTERIX, INC.
K122299 07/31/2012 SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR TRANSENTERIX, INC.


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