Cleared Traditional

K183163 - Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (FDA 510(k) Clearance)

K183163 · Motiva USA, LLC · General & Plastic Surgery device
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Feb 2019
Decision
82d
Days
-
Risk

K183163 is an FDA 510(k) clearance for the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix. Classified as Mammary Sizer (product code MRD).

Submitted by Motiva USA, LLC (New York, US). The FDA issued a Cleared decision on February 5, 2019 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K183163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2018
Decision Date February 05, 2019
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 114d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -