Panels › Gastroenterology, Urology › Product code FEI · Class 1
Instrument, Special Lens, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FEI
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic | 0 | 2 |
| American Edwards Laboratories | 1 | 0 |
| Opto Vision, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2016 | Medtronic Best Practices kits containing certain production lots of Clearify Visualization System
Item Code: 21-345
Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fog Terminated |
FEI | K062779 |
| Oct 4, 2016 | Medtronic Covidien Clearify Visualization System
Item Code: 21-345
Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens Terminated |
FEI | K062779 |
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