The following data is part of a premarket notification filed by Uro-1, Inc. with the FDA for Vmcore Biopsy Needle.
| Device ID | K201650 |
| 510k Number | K201650 |
| Device Name: | VMCore Biopsy Needle |
| Classification | Instrument, Biopsy |
| Applicant | URO-1, Inc. 111 North Chestnut Street Suite 106 Winston Salem, NC 27101 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson URO-1, Inc. 111 North Chestnut Street Suite 106 Winston Salem, NC 27101 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-18 |
| Decision Date | 2021-01-15 |