Cleared Traditional

K053151 - RUBICOR MAGIC BREAST BIOPSY DEVICE

K053151 is an FDA 510(k) clearance for RUBICOR MAGIC BREAST BIOPSY DEVICE, manufactured by Rubicor Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K053151 · Rubicor Medical, Inc. · Gastroenterology & Urology device
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Nov 2005
Decision
8d
Days
Class 2
Risk

K053151 is an FDA 510(k) clearance for the RUBICOR MAGIC BREAST BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Rubicor Medical, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Rubicor Medical, Inc. devices

FDA 510(k) Submission Details - K053151

510(k) Number K053151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2005
Decision Date November 18, 2005
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
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SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
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