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; Cassi Quadpoint Disposable.
| Device ID | K123606 |
| 510k Number | K123606 |
| Device Name: | CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE |
| Classification | Instrument, Biopsy |
| Applicant | SCION MEDICAL TECHNOLOGIES LLC 23879 BLUE SPRUCE RD Sauk Centre, MN 56378 |
| Contact | Joseph Ostendorf |
| Correspondent | Joseph Ostendorf SCION MEDICAL TECHNOLOGIES LLC 23879 BLUE SPRUCE RD Sauk Centre, MN 56378 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-03-01 |
| Summary: | summary |