The following data is part of a premarket notification filed by Uramix, Inc. with the FDA for Uramix Curaway Biopsy Needle.
| Device ID | K203141 |
| 510k Number | K203141 |
| Device Name: | Uramix CuraWay Biopsy Needle |
| Classification | Instrument, Biopsy |
| Applicant | Uramix, Inc. 272 N. Lansdowne Ave. Lansdowne, PA 19050 |
| Contact | Michael Mooreville |
| Correspondent | Michael Mooreville Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, PA 19050 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-20 |
| Decision Date | 2021-09-17 |