K221020 is an FDA 510(k) clearance for the Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Potrero Medical, Inc. (Hayward, US). The FDA issued a Cleared decision on January 13, 2023, 282 days after receiving the submission on April 6, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K221020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 06, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL - Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |