Insufflator, Automatic Carbon-Dioxide For Endoscope
FDA product code FCX · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
25510(k) clearances
0PMA approvals
2recalls
Manufacturers
- E-Z-Em, Inc. 4
- Bracco Diagnostic, Inc. 3
- Palliare , Ltd. 2
- Vision Medical, Inc. 1
- Jayco Pharmaceuticals 1
- Ide Vision, Ltd. 1
- KARL STORZ Endoscopy-America, Inc. 1
- Baronova, Inc. 1
- Fujifilm Corporation 1
- Nexcore Technology, LLC 1
- Fujifilm Medical System U.S.A., Inc. 1
- Byrne Medical, Inc. 1
- Lexion Medical, LLC 1
- Olympus Medical Systems Corp. 1
- Xylog Corp. 1
- Phx Technologies Corp. 1
- W. J. Medical Instruments, Inc. 1
- Richard Wolf Medical Instruments Corp. 1
- Keymed, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262152 | VS-370CF, VS-370CTFCX · Traditional | VISION MEDICAL Co., Ltd. | 07/24/2026SE |
| K240847 | MedicCO2LON (MedicCO2LON)FCX · Traditional | Ide Vision, Ltd. | 10/30/2024SE |
| K230474 | EVA5 InsufflatorFCX · Special | Palliare , Ltd. | 03/24/2023SE |
| K202922 | END 200 Endoscopic TubesetFCX · Traditional | Palliare , Ltd. | 07/08/2021SE |
| K201096 | CO2mbiLEDFCX · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2020SE |
| K190985 | BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional | Baronova, Inc. | 05/14/2019SESK |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special | Fujifilm Corporation | 05/25/2018SE |
| K162332 | Nexcore GI InsufflatorFCX · Traditional | Nexcore Technology, LLC | 09/29/2016SE |
| K133976 | Fujifilm Endoscopic CO2 RegulatorFCX · Traditional | Fujifilm Medical System U.S.A., Inc. | 09/09/2014SE |
| K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional | Bracco Diagnostic, Inc. | 02/14/2014SE |
| K123047 | Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetFCX · Traditional | Bracco Diagnostic, Inc. | 08/06/2013SE |
| K113310 | Endogater Avantage CO2 InsufflatorFCX · Traditional | Byrne Medical, Inc. | 06/20/2012SE |
| K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorFCX · Special | Bracco Diagnostic, Inc. | 11/03/2011SE |
| K090879 | Insuflow CO2IONSHIELDFCX · Traditional | Lexion Medical, LLC | 07/23/2009SE |
| K063786 | Endoscopic Insufflation Unit, Model XECR-2FCX · Traditional | Olympus Medical Systems Corporation | 03/05/2007SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | E-Z-Em, Inc. | 12/27/2005SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | E-Z-Em, Inc. | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | E-Z-Em, Inc. | 02/19/2002SE |
| K945970 | Insufflator Filter Tubing SetFCX · Traditional | Xylog Corp. | 12/15/1994SE |
| K930581 | E-Z-FlateFCX · Traditional | E-Z-Em, Inc. | 07/01/1994SE |
| K935059 | Insufflation Tubing Set, PHX500-082FCX · Traditional | Phx Technologies Corp. | 12/22/1993SE |
| K930508 | Hiflo Filtered Insufflation TubingFCX · Traditional | W. J. Medical Instruments, Inc. | 06/25/1993SE |
| K910716 | Model 2144.00 Combination Endo-Surgical DeviceFCX · Traditional | Richard Wolf Medical Instruments Corp. | 04/16/1991SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | Keymed, Inc. | 05/12/1988SE |
| K844689 | Endoscopic Manual Air InsufflatorFCX · Traditional | Jayco Pharmaceuticals | 01/02/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1148-2021 Class II | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 -…An internal tubing component in the flow path was made with incorrect material which was not tested for use… | Northgate Technologies, Inc. | 01/15/2021Terminated |
| Z-0084-2014 Class I | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I.…PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A… | Pentax Medical Company | 09/16/2013Terminated |