Transenterix, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2137-2012Class IISPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended fJuly 2, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K202166Senhance Surgical SystemMarch 2, 2021
K200049Senhance Surgical SystemMarch 9, 2020
K192877Senhance Surgical SystemNovember 22, 2019
K191482Senhance Surgical SystemJuly 11, 2019
K182421Senhance Ultrasonic SystemJanuary 11, 2019
K183098Senhance Surgical SystemDecember 6, 2018
K181517Senhance Surgical SystemOctober 9, 2018
K180163TransEnterix Senhance Surgical SystemMay 25, 2018
K171120Senhance Surgical Robotic SystemOctober 13, 2017
K122299SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS,October 25, 2012
K120403SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSERApril 16, 2012
K102839SPIDER STANDARD AND ADVANCEDMarch 15, 2011
K102646SPIDER FLEX MONOPOLAR HOOKNovember 3, 2010
K091697SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015September 28, 2009
K090902SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003July 22, 2009