Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set

FDA 510(k) K123047 · Bracco Diagnostic, Inc.

Substantially Equivalent

510(k) numberK123047

Submission

Device name
Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set
Applicant
Bracco Diagnostic, Inc.
Princeton, NJ, US
Received
September 28, 2012
Decision date
August 6, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCX

510(k)DeviceApplicantDecision
K262152VS-370CF, VS-370CTFCX · Traditional VISION MEDICAL Co., Ltd.07/24/2026SE
K240847MedicCO2LON (MedicCO2LON)FCX · Traditional Ide Vision, Ltd.10/30/2024SE
K230474EVA5 InsufflatorFCX · Special Palliare , Ltd.03/24/2023SE
K202922END 200 Endoscopic TubesetFCX · Traditional Palliare , Ltd.07/08/2021SE
K201096CO2mbiLEDFCX · Traditional Karl Storz Endoscopy America, Inc.06/23/2020SE
K190985BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional Baronova, Inc.05/14/2019SESK
K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special Fujifilm Corporation05/25/2018SE
K162332Nexcore GI InsufflatorFCX · Traditional Nexcore Technology, LLC09/29/2016SE
K133976Fujifilm Endoscopic CO2 RegulatorFCX · Traditional Fujifilm Medical System U.S.A., Inc.09/09/2014SE
K132192Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional Bracco Diagnostic, Inc.02/14/2014SE

More from Bracco Diagnostic, Inc.

510(k)DeviceDecision
K132192Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional 02/14/2014SE
K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorFCX · Special 11/03/2011SE

Questions and answers

When was Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set cleared by the FDA?

Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set (K123047) received a 510(k) decision of Substantially Equivalent on August 6, 2013, 312 days after the submission was received.

What is the product code of K123047?

The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.