The following data is part of a premarket notification filed by Uro-1, Inc. with the FDA for Surecore Plus Biopsy Instrument.
| Device ID | K220611 |
| 510k Number | K220611 |
| Device Name: | SUREcore Plus Biopsy Instrument |
| Classification | Instrument, Biopsy |
| Applicant | Uro-1, Inc. 3701-A Alliance Drive Greensboro, NC 27407 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson Uro-1, Inc. 3701-A Alliance Drive Greensboro, NC 27407 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-12-02 |