SMART M-CELL PRP Concentration System
K-Number: K250516 · 2026-04-02
ApplicantMiracell Co., Ltd.
Decision Date2026-04-02
Product CodeQBV
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
SMART M-CELL PRP Concentration System is a medical device manufactured by Miracell Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under approval number K250516. 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 PRP Concentration System?
SMART M-CELL PRP 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 K250516.
When was SMART M-CELL PRP Concentration System approved by the FDA?
SMART M-CELL PRP Concentration System received FDA 510(k) clearance on 2026-04-02, under approval number K250516.
What company makes SMART M-CELL PRP Concentration System?
SMART M-CELL PRP Concentration System is manufactured by Miracell Co., Ltd..
What is the FDA product code for SMART M-CELL PRP Concentration System?
The FDA product code for SMART M-CELL PRP Concentration System is QBV.
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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.