Medical Device Manufacturer · US , Durham , NC

Transenterix, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2009

Recent clearances: Senhance Surgical System, Senhance Surgical System, Senhance Surgical System

15
Total
15
Cleared
0
Denied

FDA 510(k) Regulatory Record - Transenterix, Inc. General & Plastic Surgery ✕

15 devices
1-12 of 15
Cleared Mar 02, 2021
Senhance Surgical System
K202166 · NAY
General & Plastic Surgery · 211d
Cleared Mar 09, 2020
Senhance Surgical System
K200049 · NAY
General & Plastic Surgery · 60d
Cleared Nov 22, 2019
Senhance Surgical System
K192877 · NAY
General & Plastic Surgery · 45d
Cleared Jul 11, 2019
Senhance Surgical System
K191482 · NAY
General & Plastic Surgery · 37d
Cleared Jan 11, 2019
Senhance Ultrasonic System
K182421 · NAY
General & Plastic Surgery · 128d
Cleared Dec 06, 2018
Senhance Surgical System
K183098 · NAY
General & Plastic Surgery · 29d
Cleared Oct 09, 2018
Senhance Surgical System
K181517 · NAY
General & Plastic Surgery · 123d
Cleared May 25, 2018
TransEnterix Senhance Surgical System
K180163 · NAY
General & Plastic Surgery · 126d
Cleared Oct 13, 2017
Senhance Surgical Robotic System
K171120 · NAY
General & Plastic Surgery · 182d
Cleared Oct 25, 2012
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED,...
K122299 · GCJ
General & Plastic Surgery · 86d
Cleared Apr 16, 2012
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
K120403 · GCJ
General & Plastic Surgery · 67d
Cleared Mar 15, 2011
SPIDER STANDARD AND ADVANCED
K102839 · GCJ
General & Plastic Surgery · 167d
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