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FDA 510(k)

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER

K-Number: K062421 · 2006-10-10

ApplicantMentor Corporation
Decision Date2006-10-10
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corporation. It received FDA 510(k) clearance on 2006-10-10 under 510(k) number K062421. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER?

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER is a medical device that received FDA 510(k) clearance on 2006-10-10. The listed applicant is Mentor Corporation. The 510(k) number is K062421.

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

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER received FDA 510(k) clearance on 2006-10-10, under 510(k) number K062421.

Who is the listed applicant for MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER?

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

What is the FDA product code for MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER?

The FDA product code for MENTOR RESTERILIZABLE GEL BREAST IMPLANT 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.

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Other records listing Mentor Corporation 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.

K053296MENTOR ARIS SUPRAPUBIC SURGICAL KITK052440MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK050148MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

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, LLCK131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, 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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