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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 the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2023-10-13 under 510(k) 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. The listed applicant is Motiva USA, LLC. The 510(k) number is K211676.

When did Motiva Flora SmoothSilk Tissue Expander receive FDA 510(k) clearance?

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

Who is the listed applicant for Motiva Flora SmoothSilk Tissue Expander?

The FDA 510(k) record lists Motiva USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06938399Motiva Implants® Post-Approval StudyRECRUITING

Other records listing Motiva USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230005Prosthesis, breast, noninflatable, internal, silicone gel-filledK183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

Related Devices (Code: LCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK214124AlloX2 Pro Tissue ExpandersSientra, Inc.K221127Sientra, inc. PortfinderSientra, Inc.

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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