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510(k) K250518

SMART M-CELL Bone Marrow Concentration System by Miracell Co., Ltd. — Product Code QBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
February 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Device Class
Class I
Regulation Number
862.2050
Review Panel
HE
Submission Type

To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.

Other clearances by Miracell Co., Ltd.

  • K250516 — SMART M-CELL PRP Concentration System (April 2, 2026)

Other clearances for product code QBV

  • K250516 — SMART M-CELL PRP Concentration System (April 2, 2026)