The following data is part of a premarket notification filed by Medax S.r.l. Unipersonale with the FDA for Medax Biopsy Systems Ii (medone, Medcut, Medem, Medbone, Medlock).
| Device ID | K172344 |
| 510k Number | K172344 |
| Device Name: | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) |
| Classification | Instrument, Biopsy |
| Applicant | MEDAX S.R.L. UNIPERSONALE Via R. Piva 1/A Poggio Rusco, IT 46025 |
| Contact | Stefano Cavalieri |
| Correspondent | Mario Gennari Gemar S.r.l. Via G. Puccini 1 Medolla, IT I-41036 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18056772675914 | K172344 | 000 |
| 18052286424345 | K172344 | 000 |
| 18052286424338 | K172344 | 000 |
| 18052286424949 | K172344 | 000 |
| 18053329371367 | K172344 | 000 |
| 18052286424031 | K172344 | 000 |
| 18052286423973 | K172344 | 000 |
| 18052283958980 | K172344 | 000 |
| 18059174748644 | K172344 | 000 |
| 18052286424239 | K172344 | 000 |
| 18052286424246 | K172344 | 000 |
| 18052286423614 | K172344 | 000 |
| 18052283955699 | K172344 | 000 |
| 08052283955685 | K172344 | 000 |
| 18052283959123 | K172344 | 000 |
| 18052283958997 | K172344 | 000 |
| 18052283958973 | K172344 | 000 |
| 18052286423645 | K172344 | 000 |
| 18052286423638 | K172344 | 000 |
| 18052286423621 | K172344 | 000 |
| 18059174748651 | K172344 | 000 |