K123359 is an FDA 510(k) clearance for the OVS1 VIDEO SYSTEM, a Light Source, Fiberoptic, Routine (Class II — Special Controls, product code FCW), submitted by Olive Medical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on December 19, 2012, 49 days after receiving the submission on October 31, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K123359 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2012 |
| Decision Date | December 19, 2012 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |