K153655 is an FDA 510(k) clearance for the Accuryn Monitoring System. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Potrero Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 15, 2016, 116 days after receiving the submission on December 21, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K153655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 21, 2015 |
| Decision Date | April 15, 2016 |
| Days to Decision | 116 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 |