The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Senhance Ultrasonic System.
| Device ID | K182421 |
| 510k Number | K182421 |
| Device Name: | Senhance Ultrasonic System |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville, NC 27650 |
| Contact | Stephanie M. Fitts |
| Correspondent | Stephanie M. Fitts TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville, NC 27650 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-05 |
| Decision Date | 2019-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815440021597 | K182421 | 000 |
| 00815440021580 | K182421 | 000 |
| 00815440021573 | K182421 | 000 |
| 00815440021566 | K182421 | 000 |
| 00815440021122 | K182421 | 000 |