K253797 is an FDA 510(k) clearance for the One-Stop. This device is classified as a Cord, Retraction.
Submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on February 27, 2026, 91 days after receiving the submission on November 28, 2025.
This device falls under the Dental FDA review panel.
| 510(k) Number | K253797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2025 |
| Decision Date | February 27, 2026 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |