FDA 510(k) clearance · back to tracker
SurBlate Ablation System
Mima-Pro Scientific, Inc. cleared K223272 on 2023-02-28, decision: substantially equivalent
K-number
K223272
Sponsor
Mima-Pro Scientific, Inc.
Device
SurBlate Ablation System
Class
Class II
Decision
Substantially Equivalent
Decision date
2023-02-28
Product code
NEY
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4400
Official FDA record
Open K223272on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Raw record →
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.