MedicCO2LON (MedicCO2LON)
FDA 510(k) K240847 · Ide Vision, Ltd.
510(k) numberK240847
Submission
- Device name
- MedicCO2LON (MedicCO2LON)
- Applicant
- Ide Vision, Ltd.
Caldicot, GB - Received
- March 27, 2024
- Decision date
- October 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K262152 | VS-370CF, VS-370CTFCX · Traditional | VISION MEDICAL Co., Ltd. | 07/24/2026SE |
| K230474 | EVA5 InsufflatorFCX · Special | Palliare , Ltd. | 03/24/2023SE |
| K202922 | END 200 Endoscopic TubesetFCX · Traditional | Palliare , Ltd. | 07/08/2021SE |
| K201096 | CO2mbiLEDFCX · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2020SE |
| K190985 | BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional | Baronova, Inc. | 05/14/2019SESK |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special | Fujifilm Corporation | 05/25/2018SE |
| K162332 | Nexcore GI InsufflatorFCX · Traditional | Nexcore Technology, LLC | 09/29/2016SE |
| K133976 | Fujifilm Endoscopic CO2 RegulatorFCX · Traditional | Fujifilm Medical System U.S.A., Inc. | 09/09/2014SE |
| K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional | Bracco Diagnostic, Inc. | 02/14/2014SE |
| K123047 | Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetFCX · Traditional | Bracco Diagnostic, Inc. | 08/06/2013SE |
Questions and answers
When was MedicCO2LON (MedicCO2LON) cleared by the FDA?
MedicCO2LON (MedicCO2LON) (K240847) received a 510(k) decision of Substantially Equivalent on October 30, 2024, 217 days after the submission was received.
What is the product code of K240847?
The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.