The following data is part of a premarket notification filed by Medax Srl Unipersonale with the FDA for Medone Ultra, Medextra.
| Device ID | K192101 |
| 510k Number | K192101 |
| Device Name: | Medone Ultra, Medextra |
| Classification | Instrument, Biopsy |
| Applicant | Medax Srl Unipersonale Via R.Piva, 1/A Poggio Rusco, IT 46025 |
| Contact | Stefano Cavalieri |
| Correspondent | Stefano Cavalieri Gemarmed S.R.L Via R. Piva 1/A Poggio Rusco, IT 46025 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052286423430 | K192101 | 000 |
| 18052286421719 | K192101 | 000 |
| 18052286421689 | K192101 | 000 |
| 18052286421672 | K192101 | 000 |
| 18052286421658 | K192101 | 000 |
| 18052286421634 | K192101 | 000 |
| 18052286421627 | K192101 | 000 |
| 18052286421603 | K192101 | 000 |
| 18052286421580 | K192101 | 000 |
| 18052286421573 | K192101 | 000 |
| 18052286421559 | K192101 | 000 |
| 18054301667065 | K192101 | 000 |
| 18052286421771 | K192101 | 000 |
| 18052286421610 | K192101 | 000 |
| 18052286421566 | K192101 | 000 |
| 18052286425328 | K192101 | 000 |
| 18052286427995 | K192101 | 000 |
| 18052286427988 | K192101 | 000 |
| 18052286421733 | K192101 | 000 |
| 18052286421740 | K192101 | 000 |
| 18052286423423 | K192101 | 000 |
| 18052286423416 | K192101 | 000 |
| 18052286423409 | K192101 | 000 |
| 18052286423393 | K192101 | 000 |
| 18052286423386 | K192101 | 000 |
| 18052286423379 | K192101 | 000 |
| 18052286423362 | K192101 | 000 |
| 18052286423355 | K192101 | 000 |
| 18052286423348 | K192101 | 000 |
| 18052286423331 | K192101 | 000 |
| 18052286423324 | K192101 | 000 |
| 18052286423317 | K192101 | 000 |
| 18052286423300 | K192101 | 000 |
| 18052286423294 | K192101 | 000 |
| 18052286423287 | K192101 | 000 |
| 18052286423270 | K192101 | 000 |
| 18052286423263 | K192101 | 000 |
| 18052286423690 | K192101 | 000 |