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

FDA 510(k)

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

K-Number: K242963 · 2025-04-24

ApplicantMentor Worldwide, LLC
Decision Date2025-04-24
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs 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 2025-04-24 under 510(k) number K242963. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K242963.

When did MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs receive FDA 510(k) clearance?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242963.

Who is the listed applicant for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

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 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

The FDA product code for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs 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_RECRUITINGNCT05190978Randomized Feasibility Trial for Mesh in Pre-Pectoral ReconstructionRECRUITINGNCT05975372Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast ReconstructionRECRUITINGNCT07220967A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander PlacementRECRUITING

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, salineK243271MENTOR™ 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 SizerK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

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 ExpandersAbbVieK243836Mentor™ 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.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.

↑