K990765 is an FDA 510(k) clearance for the FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO. This device is classified as a Endoscopic Guidewire, Gastroenterology-urology (Class II - Special Controls, product code OCY).
Submitted by Flexmedics (Minnetonka, US). The FDA issued a Cleared decision on March 15, 1999, 7 days after receiving the submission on March 8, 1999.
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 | K990765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1999 |
| Decision Date | March 15, 1999 |
| Days to Decision | 7 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |