Product Code: FCX FDA class 2 21 CFR 876.1500

Insufflator, Automatic Carbon-Dioxide For Endoscope

Gastroenterology, Urology

The Automatic Carbon-Dioxide Insufflator for Endoscope (product code FCX) is a device that automatically delivers controlled amounts of carbon dioxide gas to distend body cavities during endoscopic procedures, improving visualization. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FCX
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240847	MedicCO2LON (MedicCO2LON)	Oct 30, 2024	Substantially Equivalent	Ide Vision, Ltd.
K230474	EVA5 Insufflator	Mar 24, 2023	Substantially Equivalent	Palliare , Ltd.
K202922	END 200 Endoscopic Tubeset	Jul 08, 2021	Substantially Equivalent	Palliare , Ltd.
K201096	CO2mbiLED	Jun 23, 2020	Substantially Equivalent	Karl Storz Endoscopy America, Inc.
K190985	BAROnova Insufflation System, BAROnova Accessory Kit	May 14, 2019	Unknown	Baronova, Inc.
K180711	FUJIFILM Endoscopic CO2 Regulator GW-100	May 25, 2018	Substantially Equivalent	Fujifilm Corporation
K162332	Nexcore GI Insufflator	Sep 29, 2016	Substantially Equivalent	Nexcore Technology, LLC
K133976	FUJIFILM ENDOSCOPIC CO2 REGULATOR	Sep 09, 2014	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K132192	BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR	Feb 14, 2014	Substantially Equivalent	Bracco Diagnostic, Inc.
K123047	BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET	Aug 06, 2013	Substantially Equivalent	Bracco Diagnostic, Inc.
K113310	ENDOGATER AVANTAGE CO2 INSUFFLATOR	Jun 20, 2012	Substantially Equivalent	Byrne Medical, Inc.
K111648	BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR	Nov 03, 2011	Substantially Equivalent	Bracco Diagnostic, Inc.
K090879	INSUFLOW CO2IONSHIELD	Jul 23, 2009	Substantially Equivalent	Lexion Medical, LLC
K063786	ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2	Mar 05, 2007	Substantially Equivalent	Olympus Medical Systems Corporation
K053008	E-Z-EM ENDOSCOPIC CO2 REGULATOR	Dec 27, 2005	Substantially Equivalent	E-Z-Em, Inc.
K030854	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400	Apr 16, 2003	Substantially Equivalent	E-Z-Em, Inc.
K013219	PROTOCO2L INSUFFLATOR MODEL 6400	Feb 19, 2002	Substantially Equivalent	E-Z-Em, Inc.
K945970	INSUFFLATOR FILTER TUBING SET	Dec 15, 1994	Substantially Equivalent	Xylog Corp.
K930581	E-Z-FLATE	Jul 01, 1994	Substantially Equivalent	E-Z-Em, Inc.
K935059	INSUFFLATION TUBING SET, PHX500-082	Dec 22, 1993	Substantially Equivalent	Phx Technologies Corp.
K930508	HIFLO FILTERED INSUFFLATION TUBING	Jun 25, 1993	Substantially Equivalent	W. J. Medical Instruments, Inc.
K910716	MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE	Apr 16, 1991	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K881004	OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR	May 12, 1988	Substantially Equivalent	Keymed, Inc.
K844689	ENDOSCOPIC MANUAL AIR INSUFFLATOR	Jan 02, 1985	Substantially Equivalent	Jayco Pharmaceuticals