K935818 is an FDA 510(k) clearance for the ENDOSCOPE, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on July 13, 1994, 223 days after receiving the submission on December 2, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K935818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 1993 |
| Decision Date | July 13, 1994 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GDB — Endoscope, Fiber Optic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |