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FDA 510(k)

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

K-Number: K183163 · 2019-02-05

ApplicantMotiva USA, LLC
Decision Date2019-02-05
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is a medical device manufactured by Motiva USA, LLC. It received FDA 510(k) clearance on 2019-02-05 under approval number K183163. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is a medical device that received FDA 510(k) clearance on 2019-02-05. It is manufactured by Motiva USA, LLC. The 510(k) number is K183163.

When was Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix approved by the FDA?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix received FDA 510(k) clearance on 2019-02-05, under approval number K183163.

What company makes Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is manufactured by Motiva USA, LLC.

What is the FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

The FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is MRD.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT05337696 Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant TERMINATED NCT07222514 Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest RECRUITING NCT07216274 Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer COMPLETED NCT07343141 To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds NOT_YET_RECRUITING NCT04764292 Screening Contrast-Enhanced Mammography as an Alternative to MRI COMPLETED

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 41620260 [Breast implants and cancer: Anaplastic large cell lymphoma in breast implants]. Annales de chirurgie plastique et esthetique (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Motiva USA, LLC

K211676Motiva Flora SmoothSilk Tissue Expander PMA P230005Prosthesis, breast, noninflatable, internal, silicone gel-filled

Related Devices (Code: MRD)

K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc. K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use 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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