Cleared Traditional

K982258 - MAMMARY SIZER (FDA 510(k) Clearance)

K982258 · Specialty Surgical Products, Inc. · General & Plastic Surgery device
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Sep 1998
Decision
74d
Days
-
Risk

K982258 is an FDA 510(k) clearance for the MAMMARY SIZER. Classified as Mammary Sizer (product code MRD).

Submitted by Specialty Surgical Products, Inc. (Hamilton, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 74 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 Specialty Surgical Products, Inc. devices

Submission Details

510(k) Number K982258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1998
Decision Date September 08, 1998
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 114d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -

Regulatory Peers - MRD Mammary Sizer

All 12
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