K200757 is an FDA 510(k) clearance for the Foley Catheter with Temperature Sensor. This device is classified as a Catheter, Upper Urinary Tract (Class II - Special Controls, product code EYC).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 15, 2020, 205 days after receiving the submission on March 24, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K200757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYC — Catheter, Upper Urinary Tract |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |