Cleared Traditional

K955683 - RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K955683 · Contour Fabricators of Florida, Inc. · General & Plastic Surgery device
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Feb 1996
Decision
49d
Days
Class 1
Risk

K955683 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY. Classified as Device, Percutaneous, Biopsy (product code MJG), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on February 1, 1996 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. 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 Contour Fabricators of Florida, Inc. devices

Submission Details

510(k) Number K955683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date February 01, 1996
Days to Decision 49 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
65d faster than avg
Panel avg: 114d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJG Device, Percutaneous, Biopsy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.