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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K262152 | VS-370CF, VS-370CT VISION MEDICAL Co., Ltd., KR | FCX |
| Oct 30, 2024 | K240847 | MedicCO2LON (MedicCO2LON) Ide Vision, Ltd., GB | FCX |
| Mar 24, 2023 | K230474 | EVA5 Insufflator Palliare , Ltd., IE | FCX |
| Jul 8, 2021 | K202922 | END 200 Endoscopic Tubeset Palliare , Ltd., IE | FCX |
| Jun 23, 2020 | K201096 | CO2mbiLED Karl Storz Endoscopy America, Inc. | FCX |
| May 14, 2019 | K190985 | BAROnova Insufflation System, BAROnova Accessory Kit Baronova, Inc. | FCX |
| May 25, 2018 | K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 Fujifilm Corporation, JP | FCX |
| Sep 29, 2016 | K162332 | Nexcore GI Insufflator Nexcore Technology, LLC | FCX |
| Sep 9, 2014 | K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR Fujifilm Medical System U.S.A., Inc. | FCX |
| Feb 14, 2014 | K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR Bracco Diagnostic, Inc. | FCX |
| Aug 6, 2013 | K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET Bracco Diagnostic, Inc. | FCX |
| Jun 20, 2012 | K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR Byrne Medical, Inc. | FCX |
| Nov 3, 2011 | K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR Bracco Diagnostic, Inc. | FCX |
| Jul 23, 2009 | K090879 | INSUFLOW CO2IONSHIELD Lexion Medical, LLC | FCX |
| Mar 5, 2007 | K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 Olympus Medical Systems Corporation | FCX |
| Dec 27, 2005 | K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-Em, Inc. | FCX |
| Apr 16, 2003 | K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 E-Z-Em, Inc. | FCX |
| Feb 19, 2002 | K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 E-Z-Em, Inc. | FCX |
| Dec 15, 1994 | K945970 | INSUFFLATOR FILTER TUBING SET Xylog Corp. | FCX |
| Jul 1, 1994 | K930581 | E-Z-FLATE E-Z-Em, Inc. | FCX |
| Dec 22, 1993 | K935059 | INSUFFLATION TUBING SET, PHX500-082 Phx Technologies Corp. | FCX |
| Jun 25, 1993 | K930508 | HIFLO FILTERED INSUFFLATION TUBING W. J. Medical Instruments, Inc. | FCX |
| Apr 16, 1991 | K910716 | MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE Richard Wolf Medical Instruments Corp. | FCX |
| May 12, 1988 | K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR Keymed, Inc., GB | FCX |
| Jan 2, 1985 | K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR Jayco Pharmaceuticals | FCX |
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