FUJIFILM Endoscopic CO2 Regulator GW-100
FDA 510(k) K180711 · Fujifilm Corporation
510(k) numberK180711
Submission
- Device name
- FUJIFILM Endoscopic CO2 Regulator GW-100
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- March 19, 2018
- Decision date
- May 25, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K240847 | MedicCO2LON (MedicCO2LON)FCX · Traditional | Ide Vision, Ltd. | 10/30/2024SE |
| K230474 | EVA5 InsufflatorFCX · Special | Palliare , Ltd. | 03/24/2023SE |
| K202922 | END 200 Endoscopic TubesetFCX · Traditional | Palliare , Ltd. | 07/08/2021SE |
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| K190985 | BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional | Baronova, Inc. | 05/14/2019SESK |
| 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 |
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Questions and answers
When was FUJIFILM Endoscopic CO2 Regulator GW-100 cleared by the FDA?
FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711) received a 510(k) decision of Substantially Equivalent on May 25, 2018, 67 days after the submission was received.
What is the product code of K180711?
The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.