The following data is part of a premarket notification filed by Asensus Surgical, Inc. with the FDA for Senhance Surgical System.
| Device ID | K211325 |
| 510k Number | K211325 |
| Device Name: | Senhance Surgical System |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Asensus Surgical, Inc. 1 TW Alexander Drive, Suite 160 Durham, NC 27703 |
| Contact | Taylor Fisher |
| Correspondent | Taylor Fisher Asensus Surgical, Inc. 1 TW Alexander Drive, Suite 160 Durham, NC 27703 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815440021856 | K211325 | 000 |
| 00815440021825 | K211325 | 000 |