Panels › Gastroenterology, Urology › Product code FCX · Class 2
Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation 876.1500
1510(k)s in 12 months (25 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FCX
| Company | 510(k)s | Recalls |
|---|---|---|
| E-Z-Em, Inc. | 4 | 0 |
| Bracco Diagnostic, Inc. | 3 | 0 |
| Palliare , Ltd. | 2 | 0 |
| Baronova, Inc. | 1 | 0 |
| Byrne Medical, Inc. | 1 | 0 |
| Fujifilm Corporation | 1 | 0 |
| Fujifilm Medical System U.S.A., Inc. | 1 | 0 |
| Ide Vision, Ltd. | 1 | 0 |
| Jayco Pharmaceuticals | 1 | 0 |
| Karl Storz Endoscopy America, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | Northgate Technologies, Inc. Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with Terminated |
FCX | K111648 |
| Oct 28, 2013 | Pentax Medical Company PENTAX Endoscopic Accessories. OF-B194. Made in Japan.
PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used Terminated |
FCX | K850020 |
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