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FDA 510(k)

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

K-Number: K010709 · 2001-04-23

ApplicantMentor Corp.
Decision Date2001-04-23
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2001-04-23 under 510(k) number K010709. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR STERILE SALINE MAMMARY VOLUME SIZERS?

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS is a medical device that received FDA 510(k) clearance on 2001-04-23. The listed applicant is Mentor Corp.. The 510(k) number is K010709.

When did MENTOR STERILE SALINE MAMMARY VOLUME SIZERS receive FDA 510(k) clearance?

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS received FDA 510(k) clearance on 2001-04-23, under 510(k) number K010709.

Who is the listed applicant for MENTOR STERILE SALINE MAMMARY VOLUME SIZERS?

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

What is the FDA product code for MENTOR STERILE SALINE MAMMARY VOLUME SIZERS?

The FDA product code for MENTOR STERILE SALINE MAMMARY VOLUME SIZERS is MRD.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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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