Smart Medical Systems , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220158 | G-EYE System | April 11, 2022 |
| K202469 | G-EYE System | October 26, 2020 |
| K192588 | G-EYE System | April 15, 2020 |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | February 6, 2012 |
| K111760 | NAVIAID(TM) BGC DEVICE | August 9, 2011 |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE | June 17, 2011 |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | December 30, 2010 |
| K101191 | NAVIAID ICVI DEVICE | July 27, 2010 |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | August 15, 2006 |