K211224 is an FDA 510(k) clearance for the RM4 Control Unit. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Institut Georges Lopez (Lissieu, FR). The FDA issued a Cleared decision on October 15, 2021, 175 days after receiving the submission on April 23, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K211224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2021 |
| Decision Date | October 15, 2021 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN — System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |