Cleared Traditional

K113872 - THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE

K113872 is an FDA 510(k) clearance for THE ONCONTROL BONE ACCESS AND BONE BIOP..., manufactured by Vidacare Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K113872 · Vidacare Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Mar 2012
Decision
69d
Days
Class 2
Risk

K113872 is an FDA 510(k) clearance for the THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Vidacare Corporation (Irvine, US). The FDA issued a Cleared decision on March 8, 2012 after a review of 69 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 Vidacare Corporation devices

FDA 510(k) Submission Details - K113872

510(k) Number K113872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2011
Decision Date March 08, 2012
Days to Decision 69 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 131d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 306
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