Home › US Endoscopy › NA
NA
US Endoscopy · Model 710604 · UDI-DI 00816765013175
FCX
Prescription
1
510(k) clearances
551
Adverse events (6 deaths)
2
Recalls
33
Facilities
Description
The High Pressure DISS Hose for CO2 is for use with US Endoscopy CO2MPACT Insufflator, in conjunction with medical grade CO2 gas with DISS standard connector.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.