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FDA 510(k)

Sientra OPUS Silicone Gel Breast Implant Sizer

K-Number: K200706 · 2020-11-16

ApplicantSientra, Inc.
Decision Date2020-11-16
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

Sientra OPUS Silicone Gel Breast Implant Sizer is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K200706. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sientra OPUS Silicone Gel Breast Implant Sizer?

Sientra OPUS Silicone Gel Breast Implant Sizer is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Sientra, Inc.. The 510(k) number is K200706.

When did Sientra OPUS Silicone Gel Breast Implant Sizer receive FDA 510(k) clearance?

Sientra OPUS Silicone Gel Breast Implant Sizer received FDA 510(k) clearance on 2020-11-16, under 510(k) number K200706.

Who is the listed applicant for Sientra OPUS Silicone Gel Breast Implant Sizer?

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

What is the FDA product code for Sientra OPUS Silicone Gel Breast Implant Sizer?

The FDA product code for Sientra OPUS Silicone 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.

NCT06013514Post-market Prospective Clinical Study of Nagor Perle Mammary ImplantsRECRUITINGNCT05437757Scaffold-guided Breast SurgeryCOMPLETEDNCT07367698Scaffold-guided Breast Implant Revision and Primary Breast Augmentation SurgeryRECRUITING

Other records listing Sientra, Inc. 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.

K214124AlloX2 Pro Tissue ExpandersK221127Sientra, inc. Portfinder

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 ImplantsAllerganK183163Intraoperative, 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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