TransEnterix Senhance Surgical System is an AI-enabled medical device from TransEnterix, Inc. that the U.S. FDA cleared through 510(k) K180163 on May 25, 2018. Its lead review panel is Gastroenterology-Urology and its primary product code is NAY (System, Surgical, Computer Controlled Instrument).
See also all FDA AI clearances in 2018, top gastroenterology-urology AI devices.
Key facts
| Submission number | K180163 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | TransEnterix, Inc. |
| Lead review panel | Gastroenterology-Urology |
| Primary product code | NAY — System, Surgical, Computer Controlled Instrument |
| Applicant (openFDA) | Transenterix, Inc. |
| Applicant location | Morrisville, NC, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.1500 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. TransEnterix Senhance Surgical System went through this pathway (K180163).
openFDA lists it as a Class 2 device under 21 CFR 876.1500. Class II devices are moderate risk and are subject to general and special controls.
Product code NAY covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. TransEnterix, Inc. has 1 AI-enabled device on the list, and the Gastroenterology-Urology panel accounts for 27 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.