Cleared Traditional

K243271 - MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer (FDA 510(k) Clearance)

Also includes:
MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
K243271 · Mentor Worldwide, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
89d
Days
-
Risk

K243271 is an FDA 510(k) clearance for the MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Worldwide, LLC (Irvine, US). The FDA issued a Cleared decision on January 13, 2025 after a review of 89 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 Mentor Worldwide, LLC devices

Submission Details

510(k) Number K243271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2024
Decision Date January 13, 2025
Days to Decision 89 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
25d faster than avg
Panel avg: 114d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -