K926344 is an FDA 510(k) clearance for the HYDROPHILIC COATED GUIDEWIRE, a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 5, 1993, 78 days after receiving the submission on December 17, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K926344 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 17, 1992 |
| Decision Date | March 05, 1993 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |