Panels › Gastroenterology, Urology › Product code FCY · Class 1
Bulb, Inflation, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FCY
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomedical Dynamics, Inc. | 1 | 0 |
| CIVCO Medical Instruments Co., Inc. | 1 | 0 |
| Zutron Medical, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2010 | K093718 | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 Zutron Medical, LLC | FCY |
| Dec 20, 1990 | K904376 | ANEROID BLOOD PRESSURE GAUGE Biomedical Dynamics, Inc. | FCY |
| Jun 11, 1990 | K900016 | TRANS/R - FP(3) CIVCO Medical Instruments Co., Inc. | FCY |
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