K123439 is an FDA 510(k) clearance for the NEO ERCP GUIDEWIRE, a Endoscopic Guidewire, Gastroenterology-urology (Class II — Special Controls, product code OCY), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 3, 2013, 56 days after receiving the submission on November 8, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K123439 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 2012 |
| Decision Date | January 03, 2013 |
| Days to Decision | 56 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. |