FCX · Class II · 21 CFR 876.1500

FDA Product Code FCX: Insufflator, Automatic Carbon-dioxide For Endoscope

Leading manufacturers include E-Z-Em, Inc., Palliare , Ltd. and Olympus Medical Systems Corporation.

25
Total
25
Cleared
128d
Avg days
1985
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 123d avg (recent)

FDA 510(k) Cleared Insufflator, Automatic Carbon-dioxide For Endoscope Devices (Product Code FCX)

25 devices
1–24 of 25
Cleared Oct 30, 2024
MedicCO2LON (MedicCO2LON)
K240847
Ide Vision, Ltd.
Gastroenterology & Urology · 217d
Cleared Mar 24, 2023
EVA5 Insufflator
K230474
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 08, 2021
END 200 Endoscopic Tubeset
K202922
Palliare , Ltd.
Gastroenterology & Urology · 282d
Cleared Jun 23, 2020
CO2mbiLED
K201096
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 60d
Cleared May 14, 2019
BAROnova Insufflation System, BAROnova Accessory Kit
K190985
Baronova, Inc.
Gastroenterology & Urology · 29d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711
Fujifilm Corporation
Gastroenterology & Urology · 67d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Mar 05, 2007
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786
Olympus Medical Systems Corporation
Gastroenterology & Urology · 74d
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008
E-Z-Em, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Jul 01, 1994
E-Z-FLATE
K930581
E-Z-Em, Inc.
Gastroenterology & Urology · 512d
Cleared Dec 22, 1993
INSUFFLATION TUBING SET, PHX500-082
K935059
Phx Technologies Corp.
Gastroenterology & Urology · 62d
Cleared Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 55d

About Product Code FCX - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code FCX since 1985, with 25 receiving FDA clearance (average review time: 128 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FCX Product Code

FDA review times for FCX submissions have been consistent, averaging 123 days recently vs 129 days historically.

FCX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →