K142397 is an FDA 510(k) clearance for the Predicate III Guidewire, 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 September 19, 2014, 23 days after receiving the submission on August 27, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K142397 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2014 |
| Decision Date | September 19, 2014 |
| Days to Decision | 23 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. |