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FDA 510(k)

MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER

K-Number: K131853 · 2013-07-17

ApplicantMentor Worldwide, LLC
Decision Date2013-07-17
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

MENTOR MEMORYSHAPE RESTERILIZABLE 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 2013-07-17 under 510(k) number K131853. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER?

MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER is a medical device that received FDA 510(k) clearance on 2013-07-17. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K131853.

When did MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER receive FDA 510(k) clearance?

MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER received FDA 510(k) clearance on 2013-07-17, under 510(k) number K131853.

Who is the listed applicant for MENTOR MEMORYSHAPE RESTERILIZABLE 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 MEMORYSHAPE RESTERILIZABLE GEL SIZER?

The FDA product code for MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER is MRD.

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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.

K242963MENTOR™ 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 SizerK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderK182335CPX 4 Breast Tissue Expander with Smooth Surface

View all 9 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, LLCK241552MENTOR™ 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, LLCK062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMentor Corporation

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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