VS-370CF, VS-370CT

FDA 510(k) K262152 · VISION MEDICAL Co., Ltd.

Substantially Equivalent

510(k) numberK262152

Submission

Device name
VS-370CF, VS-370CT
Applicant
VISION MEDICAL Co., Ltd.
Incheon, KR
Received
June 25, 2026
Decision date
July 24, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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

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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
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
K913273Drolite(Tm) Light SourceHJM · Traditional 12/04/1991SE
K913837Microscis(Tm) Introcular Scissor SystemHQE · Traditional 11/05/1991SE

Questions and answers

When was VS-370CF, VS-370CT cleared by the FDA?

VS-370CF, VS-370CT (K262152) received a 510(k) decision of Substantially Equivalent on July 24, 2026, 29 days after the submission was received.

What is the product code of K262152?

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