K122816 is an FDA 510(k) clearance for the AXCESS SOFT TIP WIRE GUIDE. This device is classified as a Endoscopic Guidewire, Gastroenterology-urology (Class II - Special Controls, product code OCY).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 9, 2012, 25 days after receiving the submission on September 14, 2012.
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 | K122816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2012 |
| Decision Date | October 09, 2012 |
| Days to Decision | 25 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. |