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FDA 510(k)

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

K-Number: K241552 · 2024-09-06

ApplicantMentor Worldwide, LLC
Decision Date2024-09-06
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer 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 2024-09-06 under 510(k) number K241552. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K241552.

When did MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer receive FDA 510(k) clearance?

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241552.

Who is the listed applicant for MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

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™ MemoryGel™ Enhance Single Use Gel Sizer?

The FDA product code for MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is MRD.

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_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 ExpanderK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

View all 10 devices →

Related Devices (Code: MRD)

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.

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllerganK200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC

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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