K240847 is an FDA 510(k) clearance for the MedicCO2LON (MedicCO2LON). This device is classified as a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II - Special Controls, product code FCX).
Submitted by Ide Vision, Ltd. (Caldicot, GB). The FDA issued a Cleared decision on October 30, 2024, 217 days after receiving the submission on March 27, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K240847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2024 |
| Decision Date | October 30, 2024 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCX - Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |