Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator

FDA 510(k) K132192 · Bracco Diagnostic, Inc.

Substantially Equivalent

510(k) numberK132192

Submission

Device name
Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator
Applicant
Bracco Diagnostic, Inc.
Monroe Township, NJ, US
Received
July 15, 2013
Decision date
February 14, 2014
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

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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
K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetFCX · Traditional Bracco Diagnostic, Inc.08/06/2013SE

More from Bracco Diagnostic, Inc.

510(k)DeviceDecision
K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetFCX · Traditional 08/06/2013SE
K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorFCX · Special 11/03/2011SE

Questions and answers

When was Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator cleared by the FDA?

Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator (K132192) received a 510(k) decision of Substantially Equivalent on February 14, 2014, 214 days after the submission was received.

What is the product code of K132192?

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