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FDA 510(k)

KTA Adipose Treatment Kit

K-Number: K190386 · 2019-10-10

ApplicantStemics S.A.S
Decision Date2019-10-10
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KTA Adipose Treatment Kit is a medical device manufactured by Stemics S.A.S. It received FDA 510(k) clearance on 2019-10-10 under approval number K190386. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KTA Adipose Treatment Kit?

KTA Adipose Treatment Kit is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Stemics S.A.S. The 510(k) number is K190386.

When was KTA Adipose Treatment Kit approved by the FDA?

KTA Adipose Treatment Kit received FDA 510(k) clearance on 2019-10-10, under approval number K190386.

What company makes KTA Adipose Treatment Kit?

KTA Adipose Treatment Kit is manufactured by Stemics S.A.S.

What is the FDA product code for KTA Adipose Treatment Kit?

The FDA product code for KTA Adipose Treatment Kit is MUU.

Related Clinical Trials

NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT07544537 A Prospective Comparative Study of Autologous Bone Marrow-Derived and Adipose Tissue-Derived Mesenchymal Stem Cells Versus Platelet-Rich Plasma and Standard Therapy in Patients With Organic Erectile Dysfunction ACTIVE_NOT_RECRUITING NCT05594862 Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

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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.

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