510(k) K253797
K253797 is an FDA 510(k) premarket notification submitted by Mediclus Co., Ltd. for the device "One-Stop". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code MVL (Cord, Retraction), a Class U device. Mediclus Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2026
- Date Received
- November 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type