K961536 is an FDA 510(k) clearance for the FLEXSCOPE, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Matrix Medica, Inc. (Burnsville, US). The FDA issued a Cleared decision on September 18, 1996, 149 days after receiving the submission on April 22, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K961536 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 1996 |
| Decision Date | September 18, 1996 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GDB — Endoscope, Fiber Optic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |