The following data is part of a premarket notification filed by Scion Medical Technologies, Llc with the FDA for Cassi Ii Rotational Core Biopsy System.
| Device ID | K161234 |
| 510k Number | K161234 |
| Device Name: | CASSI II Rotational Core Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | Scion Medical Technologies, LLC 4613 West Chester Pike Newton Square, PA 19073 |
| Contact | Louis Li |
| Correspondent | Louis Li Scion Medical Technologies, LLC 4613 West Chester Pike Newton Square, PA 19073 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866479000152 | K161234 | 000 |
| 00866479000145 | K161234 | 000 |
| 10866479000135 | K161234 | 000 |
| 10866479000128 | K161234 | 000 |