K112106 is an FDA 510(k) clearance for the NAVIAID ICVI-F,S,B,R DEVICE. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Smart Medical Systems , Ltd. (Raanana, IL). The FDA issued a Cleared decision on February 6, 2012, 199 days after receiving the submission on July 22, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K112106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2011 |
| Decision Date | February 06, 2012 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC - Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |