One-Stop— 510(k) K253797
Substantially EquivalentMediclus Co., Ltd.
FDA 510(k) clearance K253797 for One-Stop, Substantially Equivalent on 2026-02-27. Applicant: Mediclus Co., Ltd.. Device class: Unclassified.
Summary
Mediclus filed a device named only One-Stop under product code MVL, retraction cord. The name is generic, and the record doesn't describe the device further.
Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).
Mediclus filed from Cheongju-Si, South Korea. Review took 91 calendar days (November 28, 2025 to February 27, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Mediclus Co., Ltd.
- Product code
- Product code MVL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
Recent devices under product code MVL
view allMore clearances from Mediclus Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.