Cleared Special

K131853 - MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (FDA 510(k) Clearance)

K131853 · Mentor Worldwide, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
26d
Days
-
Risk

K131853 is an FDA 510(k) clearance for the MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K131853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date July 17, 2013
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 114d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRD Mammary Sizer
Device Class -