K063309 is an FDA 510(k) clearance for the TRU-CABLE, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Truphatek International, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on January 12, 2007, 71 days after receiving the submission on November 2, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K063309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |