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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 1988 | K873795 | M-LENS (THIRTY DEGREE ENDOSCOPE) Opto Vision, Inc. | FEI |
| Oct 24, 1986 | K862872 | FLEXIBLE VISUALIZATION CATHETER American Edwards Laboratories | FEI |
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