Cleared Special

K151055 - Mentor MemoryShape Resterilizable Gel B...

K151055 · Mentor Worldwide, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
30d
Days
-
Risk

K151055 is an FDA 510(k) clearance for the Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on May 20, 2015 after a review of 30 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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FDA 510(k) Submission Details - K151055

510(k) Number K151055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date May 20, 2015
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MRD Device Classification - Class 0,

Product Code MRD Mammary Sizer
Device Class -

Regulatory Peers - MRD Mammary Sizer

Devices cleared under the same product code (MRD) and FDA review panel - the closest regulatory comparables to K151055.
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K010709 · Mentor Corp. · Apr 2001