The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Encor Breast Biopsy Probe With Rinse Tube.
| Device ID | K210654 |
| 510k Number | K210654 |
| Device Name: | EnCor Breast Biopsy Probe With Rinse Tube |
| Classification | Instrument, Biopsy |
| Applicant | SenoRx, Inc. 1625 West 3rd Street Tempe, AZ 85251 |
| Contact | Jessica Myer |
| Correspondent | Jessica Myer SenoRx, Inc. 1625 West 3rd Street Tempe, AZ 85251 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2021-03-31 |