Cleared Traditional

K010709 - MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (FDA 510(k) Clearance)

K010709 · Mentor Corp. · General & Plastic Surgery device
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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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 114d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -