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 |