Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Motiva Flora SmoothSilk Tissue Expander

K-Number: K211676 · 2023-10-13

ApplicantMotiva USA, LLC
Decision Date2023-10-13
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Motiva Flora SmoothSilk Tissue Expander is a medical device manufactured by Motiva USA, LLC. It received FDA 510(k) clearance on 2023-10-13 under approval number K211676. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Motiva Flora SmoothSilk Tissue Expander?

Motiva Flora SmoothSilk Tissue Expander is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Motiva USA, LLC. The 510(k) number is K211676.

When was Motiva Flora SmoothSilk Tissue Expander approved by the FDA?

Motiva Flora SmoothSilk Tissue Expander received FDA 510(k) clearance on 2023-10-13, under approval number K211676.

What company makes Motiva Flora SmoothSilk Tissue Expander?

Motiva Flora SmoothSilk Tissue Expander is manufactured by Motiva USA, LLC.

What is the FDA product code for Motiva Flora SmoothSilk Tissue Expander?

The FDA product code for Motiva Flora SmoothSilk Tissue Expander is LCJ.

Related Clinical Trials

NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05190978 Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction RECRUITING NCT07220967 A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement RECRUITING

Other Devices by Motiva USA, LLC

K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix PMA P230005Prosthesis, breast, noninflatable, internal, silicone gel-filled

Related Devices (Code: LCJ)

K161483Unger Quad InjectorStradis Healthcare K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC K182054Natrelle 133S Tissue ExpanderAllergan

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.

↑