K922826 is an FDA 510(k) clearance for the FLEXIBLE FIBER OPTIC ENDOSCOPE. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by Optimed Technologies, Inc. (Orange, US). The FDA issued a Cleared decision on February 19, 1993, 253 days after receiving the submission on June 11, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K922826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1992 |
| Decision Date | February 19, 1993 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGA — Kit, Nephroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |