K193361 is an FDA 510(k) clearance for the ProCell Surgical Sponge-Blood Recovery Unit. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Procell Surgical, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 1, 2020, 180 days after receiving the submission on December 4, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K193361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2019 |
| Decision Date | June 01, 2020 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC - Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |