K150927 is an FDA 510(k) clearance for the Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff. This device is classified as a Endoscopic Guidewire, Gastroenterology-urology (Class II - Special Controls, product code OCY).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on May 27, 2015, 51 days after receiving the submission on April 6, 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 | K150927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2015 |
| Decision Date | May 27, 2015 |
| Days to Decision | 51 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. |