Home › Device types › FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
FDA product code FCX · Class 2 · Gastroenterology, Urology
88
Registered devices
540
Adverse events
2
Recalls
25
510(k) clearances
Devices with this code
CO2 Source Tubing — Zhejiang Chuangxiang Medical Technology Co., LTD.NA — US EndoscopyProtocol Administration Set with Small Catheter and Retention Cuff — Bracco Diagnostics Inc.NA — US EndoscopyCO2EFFICIENT — US EndoscopyNA — Richard Wolf GmbHFOOT SWITCH — OLYMPUS MEDICAL SYSTEMS CORP.NA — US EndoscopyNOVADAQ®and PINPOINT® — Novadaq Technologies IncENDOFLATOR — Karl Storz GmbH & Co. KGCO2MPACT — US EndoscopyProtocol Colon Insufflator — Bracco Diagnostics Inc.EXTRA LOW FLOW GAS TUBE — OLYMPUS MEDICAL SYSTEMS CORP.ENDOSCOPIC CO2 REGULATION UNIT — OLYMPUS MEDICAL SYSTEMS CORP.DIN 477 High Pressure Hose for CO2 — Bracco Diagnostics Inc.NA — US EndoscopyNA — US EndoscopyNA — US EndoscopyProtocol Touch Colon Insufflator Demo Unit — Bracco Diagnostics Inc.Protocol Administration Set With Flexi-Cuff Retention Tip — Bracco Diagnostics Inc.High Pressure Hose and Yoke — Bracco Diagnostics Inc.FUJIFILM — FUJIFILM CORPORATIONENDOSCOPIC CO2 REGULATION UNIT — OLYMPUS MEDICAL SYSTEMS CORP.NA — Richard Wolf GmbH
Recent 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 C |
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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.