The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Transenterix Senhance Surgical System.
Device ID | K180163 |
510k Number | K180163 |
Device Name: | TransEnterix Senhance Surgical System |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560 |
Contact | Stephanie Fitts |
Correspondent | Stephanie Fitts TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-19 |
Decision Date | 2018-05-25 |
Summary: | summary |