One-Stop
510(k) K253797
One-Stop is a medical device (FDA unclassified; FDA product code MVL, Cord, Retraction) made by MEDICLUS Co., Ltd., cleared under FDA 510(k) K253797 on 27 Feb 2026, active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253797 | Date27 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K253797
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MVL
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
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