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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 a medical device manufactured by Sientra, Inc.. It received FDA 510(k) clearance on 2020-11-16 under approval 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. It is manufactured by Sientra, Inc.. The 510(k) number is K200706.

When was Sientra OPUS Silicone Gel Breast Implant Sizer approved by the FDA?

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

What company makes Sientra OPUS Silicone Gel Breast Implant Sizer?

Sientra OPUS Silicone Gel Breast Implant Sizer is manufactured by Sientra, Inc..

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

NCT04764292 Screening Contrast-Enhanced Mammography as an Alternative to MRI COMPLETED NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING NCT05585710 Pulsed Lavage in Implant-Based Breast Reconstruction RECRUITING NCT06511167 Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery RECRUITING NCT07135596 Effectiveness and Safety of OviTex® PRS in Breast Reconstruction RECRUITING NCT05190978 Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction RECRUITING

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)

Other Devices by Sientra, Inc.

K214124AlloX2 Pro Tissue Expanders K221127Sientra, inc. Portfinder

Related Devices (Code: MRD)

K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC 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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