K082536 is an FDA 510(k) clearance for the COOK WIRE GUIDES, a Endoscopic Guidewire, Gastroenterology-urology (Class II — Special Controls, product code OCY), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 27, 2008, 55 days after receiving the submission on September 2, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K082536 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 2008 |
| Decision Date | October 27, 2008 |
| Days to Decision | 55 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. |