K240847 is an FDA 510(k) clearance for the MedicCO2LON (MedicCO2LON), 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 review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K240847 FDA.gov |
| FDA Decision | Cleared 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 |