Cleared Special

K161234 - CASSI II Rotational Core Biopsy System

K161234 is an FDA 510(k) clearance for CASSI II Rotational Core Biopsy System, manufactured by Scion Medical Technologies, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 93-day FDA review.

K161234 · Scion Medical Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
93d
Days
Class 2
Risk

K161234 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 (Newtown Square, US). The FDA issued a Cleared decision on August 3, 2016 after a review of 93 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

FDA 510(k) Submission Details - K161234

510(k) Number K161234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date August 03, 2016
Days to Decision 93 days
Submission Type Special
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
38d faster than avg
Panel avg: 131d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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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