Cleared Traditional

K062421 - MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER

K062421 · Mentor Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
53d
Days
-
Risk

K062421 is an FDA 510(k) clearance for the MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Corporation (Santa Barbara, US). The FDA issued a Cleared decision on October 10, 2006 after a review of 53 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.

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FDA 510(k) Submission Details - K062421

510(k) Number K062421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2006
Decision Date October 10, 2006
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

MRD Device Classification - Class 0,

Product Code MRD Mammary Sizer
Device Class -

Regulatory Peers - MRD Mammary Sizer

All 11
Devices cleared under the same product code (MRD) and FDA review panel - the closest regulatory comparables to K062421.
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MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
K131853 · Mentor Worldwide, LLC · Jul 2013
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709 · Mentor Corp. · Apr 2001
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
K984106 · Specialty Surgical Products, Inc. · Feb 1999
MAMMARY SIZER
K982258 · Specialty Surgical Products, Inc. · Sep 1998