Cleared Traditional

K241552 - MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (FDA 510(k) Clearance)

K241552 · Mentor Worldwide, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2024
Decision
98d
Days
-
Risk

K241552 is an FDA 510(k) clearance for the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Worldwide, LLC (Irvine, US). The FDA issued a Cleared decision on September 6, 2024 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K241552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date September 06, 2024
Days to Decision 98 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
16d faster than avg
Panel avg: 114d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -