Cleared Traditional

K010709 - MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

K010709 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
45d
Days
-
Risk

K010709 is an FDA 510(k) clearance for the MENTOR STERILE SALINE MAMMARY VOLUME SIZERS. Classified as Mammary Sizer (product code MRD).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on April 23, 2001 after a review of 45 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 Corp. devices

FDA 510(k) Submission Details - K010709

510(k) Number K010709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date April 23, 2001
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 K010709.
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
K151055 · Mentor Worldwide, LLC · May 2015
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
K131853 · Mentor Worldwide, LLC · Jul 2013
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
K062421 · Mentor Corporation · Oct 2006
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
K984106 · Specialty Surgical Products, Inc. · Feb 1999
MAMMARY SIZER
K982258 · Specialty Surgical Products, Inc. · Sep 1998
MAMMARY SIZER
K961356 · General Surgical Innovations · Sep 1996