Cleared Traditional

K183163 - Intraoperative

K183163 · Motiva USA, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Motiva USA, LLC devices

FDA 510(k) Submission Details - K183163

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

MRD Device Classification - Class 0,

Product Code MRD Mammary Sizer
Device Class -

Regulatory Consultant

Experien Group, LLC
Michael J. Billig

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRD Mammary Sizer

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