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US Endoscopy · Model 710602 · UDI-DI 00816765013151
FCX
Prescription
1
510(k) clearances
540
Adverse events (6 deaths)
2
Recalls
33
Facilities
Description
The Two tank shuttle valve system is for use with an insufflator to attach two medical grade CO2 cylinders simultaneously. This reduces the likelihood of running out of CO2 during a procedure.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-15 | Northgate Technologies, Inc. | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| 2013-09-16 | Pentax Medical Company | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an end |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.