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FDA 510(k)

SMART M-CELL Bone Marrow Concentration System

K-Number: K250518 · 2026-04-02

ApplicantMiracell Co., Ltd.
Decision Date2026-04-02
Product CodeQBV
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMART M-CELL Bone Marrow Concentration System is a medical device manufactured by Miracell Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under approval number K250518. The device is classified under product code QBV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART M-CELL Bone Marrow Concentration System?

SMART M-CELL Bone Marrow Concentration System is a medical device that received FDA 510(k) clearance on 2026-04-02. It is manufactured by Miracell Co., Ltd.. The 510(k) number is K250518.

When was SMART M-CELL Bone Marrow Concentration System approved by the FDA?

SMART M-CELL Bone Marrow Concentration System received FDA 510(k) clearance on 2026-04-02, under approval number K250518.

What company makes SMART M-CELL Bone Marrow Concentration System?

SMART M-CELL Bone Marrow Concentration System is manufactured by Miracell Co., Ltd..

What is the FDA product code for SMART M-CELL Bone Marrow Concentration System?

The FDA product code for SMART M-CELL Bone Marrow Concentration System is QBV.

Related Clinical Trials

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Other Devices by Miracell Co., Ltd.

K250516SMART M-CELL PRP Concentration System

Related Devices (Code: QBV)

K250516SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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