Transenterix, Inc.
Medical device manufacturer in Morrisville, NC.
15510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K202166 | Senhance Surgical SystemNAY · Traditional | 03/02/2021SE |
| K200049 | Senhance Surgical SystemNAY · Traditional | 03/09/2020SE |
| K192877 | Senhance Surgical SystemNAY · Special | 11/22/2019SE |
| K191482 | Senhance Surgical SystemNAY · Special | 07/11/2019SE |
| K182421 | Senhance Ultrasonic SystemNAY · Traditional | 01/11/2019SE |
| K183098 | Senhance Surgical SystemNAY · Special | 12/06/2018SE |
| K181517 | Senhance Surgical SystemNAY · Traditional | 10/09/2018SE |
| K180163 | TransEnterix Senhance Surgical SystemNAY · Traditional | 05/25/2018SE |
| K171120 | Senhance Surgical Robotic SystemNAY · Traditional | 10/13/2017SE |
| K122299 | Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…GCJ · Traditional | 10/25/2012SE |
| K120403 | Spider Flexible Blunt Dissector and Band PasserGCJ · Traditional | 04/16/2012SE |
| K102839 | Spider Standard and AdvancedGCJ · Special | 03/15/2011SE |
| K102646 | Spider Flex Monopolar HookGCJ · Special | 11/03/2010SE |
| K091697 | Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015GCJ · Traditional | 09/28/2009SE |
| K090902 | Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003GCJ · Traditional | 07/22/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2137-2012 Class II | SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are…Some clip applier units may be inadequate to achieve clip closure. | 07/02/2012Terminated |
| Z-1910-2011 | SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to…Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery. | 02/25/2011Terminated |
| Z-1909-2011 | SPIDER Surgical Platform The SPIDER is a single port, single incision device to…Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery. | 02/25/2011Terminated |
| Z-2465-2010 | Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NCThe hook end effecter from a monopolar device may become dislodged and fall into the patient when in use… | 06/22/2010Terminated |