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FDA 510(k)

ARTOURA Breast Tissue Expanders with Smooth Surface

K-Number: K161176 · 2016-05-23

ApplicantMentor Worldwide, LLC
Decision Date2016-05-23
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

ARTOURA Breast Tissue Expanders with Smooth Surface is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K161176. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTOURA Breast Tissue Expanders with Smooth Surface?

ARTOURA Breast Tissue Expanders with Smooth Surface is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K161176.

When did ARTOURA Breast Tissue Expanders with Smooth Surface receive FDA 510(k) clearance?

ARTOURA Breast Tissue Expanders with Smooth Surface received FDA 510(k) clearance on 2016-05-23, under 510(k) number K161176.

Who is the listed applicant for ARTOURA Breast Tissue Expanders with Smooth Surface?

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

What is the FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface?

The FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface 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.

NCT02724371A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision ReconstructionACTIVE_NOT_RECRUITINGNCT02919592Memory Gel and Shape Combined CohortACTIVE_NOT_RECRUITINGNCT07220967A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander PlacementRECRUITINGNCT07527468HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving SurgeryNOT_YET_RECRUITING

Other records listing Mentor Worldwide, 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 P060028Prosthesis, breast, noninflatable, internal, silicone gel-filledPMA P990075Prosthesis, breast, inflatable, internal, salineK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsK243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderK241552MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

View all 10 devices →

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, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, 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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