The following data is part of a premarket notification filed by Transenterix Inc. with the FDA for Senhance Surgical System.
| Device ID | K191482 |
| 510k Number | K191482 |
| Device Name: | Senhance Surgical System |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | TransEnterix Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560 |
| Contact | Kaitlyn Alexander |
| Correspondent | Kaitlyn Alexander TransEnterix Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-04 |
| Decision Date | 2019-07-11 |