Cleared Traditional

MAMMARY SIZER (K961356) - FDA 510(k) Clearance

K961356 · General Surgical Innovations · General & Plastic Surgery device
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Sep 1996
Decision
168d
Days
-
Risk

K961356 is an FDA 510(k) clearance for the MAMMARY SIZER. Classified as Mammary Sizer (product code MRD).

Submitted by General Surgical Innovations (Palo Alto, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all General Surgical Innovations devices

Submission Details

510(k) Number K961356 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 08, 1996
Decision Date September 23, 1996
Days to Decision 168 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -