K140482 is an FDA 510(k) clearance for the MANDREL GUIDEWIRE. This device is classified as a Endoscopic Guidewire, Gastroenterology-urology (Class II - Special Controls, product code OCY).
Submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on April 8, 2014, 41 days after receiving the submission on February 26, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories..
| 510(k) Number | K140482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2014 |
| Decision Date | April 08, 2014 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCY — Endoscopic Guidewire, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories. |