The following data is part of a premarket notification filed by Argon Medical Devices with the FDA for Novacore Semi-automatic Biopsy Instrument.
| Device ID | K213232 |
| 510k Number | K213232 |
| Device Name: | NovaCore Semi-Automatic Biopsy Instrument |
| Classification | Instrument, Biopsy |
| Applicant | Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 |
| Contact | Daniel Lanois |
| Correspondent | Scott Bishop Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-07-01 |