K151471 is an FDA 510(k) clearance for the Radifocus Glidewire Endoscopic Wire. This device is classified as a Endoscopic Guidewire, Gastroenterology-urology (Class II - Special Controls, product code OCY).
Submitted by Terumo Medical Corporation (Somerset, US). The FDA issued a Cleared decision on September 17, 2015, 108 days after receiving the submission on June 1, 2015.
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 | K151471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2015 |
| Decision Date | September 17, 2015 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| 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. |