Cleared Special

K123606 - CASSI II ROTATIONAL CORE BIOPSY SYSTEM (FDA 510(k) Clearance)

Also includes:
CASSI QUADPOINT DISPOSABLE

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123606 · Scion Medical Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
100d
Days
Class 2
Risk

K123606 is an FDA 510(k) clearance for the CASSI II ROTATIONAL CORE BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Scion Medical Technologies, LLC (Sauk Centre, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scion Medical Technologies, LLC devices

Submission Details

510(k) Number K123606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date March 01, 2013
Days to Decision 100 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 359
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