K143024 is an FDA 510(k) clearance for the CAS-One Liver. This device is classified as a Tracking, Soft Tissue, Intraoperative (Class II - Special Controls, product code OEW).
Submitted by Cascination AG (Bern, CH). The FDA issued a Cleared decision on April 28, 2015, 189 days after receiving the submission on October 21, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.4560. For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia..
| 510(k) Number | K143024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2014 |
| Decision Date | April 28, 2015 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OEW - Tracking, Soft Tissue, Intraoperative |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia. |