K061918 is an FDA 510(k) clearance for the FOLEY CATHETERS WITH TEMPERATURE PROBE. This device is classified as a Catheter, Upper Urinary Tract (Class II - Special Controls, product code EYC).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on August 18, 2006, 43 days after receiving the submission on July 6, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K061918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2006 |
| Decision Date | August 18, 2006 |
| Days to Decision | 43 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 |