K241410 is an FDA 510(k) clearance for the EDEN ControlCath. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Jmt Co., Ltd. (Yangju-Si, KR). The FDA issued a Cleared decision on February 13, 2025, 272 days after receiving the submission on May 17, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K241410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2024 |
| Decision Date | February 13, 2025 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSO - Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |