Cleared Traditional

K062159 - RB12 SUCTION RECTAL BIOPSY SYSTEM

K062159 is an FDA 510(k) clearance for RB12 SUCTION RECTAL BIOPSY SYSTEM, manufactured by Aus Systems Pty , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCK cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K062159 · Aus Systems Pty , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Sep 2006
Decision
39d
Days
Class 2
Risk

K062159 is an FDA 510(k) clearance for the RB12 SUCTION RECTAL BIOPSY SYSTEM. Classified as Instrument, Biopsy, Suction (product code FCK), Class II - Special Controls.

Submitted by Aus Systems Pty , Ltd. (Clearwater, US). The FDA issued a Cleared decision on September 5, 2006 after a review of 39 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 Aus Systems Pty , Ltd. devices

FDA 510(k) Submission Details - K062159

510(k) Number K062159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2006
Decision Date September 05, 2006
Days to Decision 39 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCK Device Classification - Class 2, Special Controls

Product Code FCK Instrument, Biopsy, Suction
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 - FCK Instrument, Biopsy, Suction

All 7
Devices cleared under the same product code (FCK) and FDA review panel - the closest regulatory comparables to K062159.
Howell Biliary Aspiration Needle
K153763 · Wilson-Cook Medical, Inc. · Apr 2017
MULTIPLE BIOPSY SYSTEM
K103326 · United States Endoscopy Group, Inc. · Apr 2011
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
K061201 · United States Endoscopy Group, Inc. · May 2006
DSNARE, MODEL 00711087
K051637 · United States Endoscopy Group, Inc. · Oct 2005
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · United States Endoscopy Group, Inc. · Oct 1995
SUCTION BIOPSY INSTRUMENT
K895420 · Mill-Rose Laboratory · Feb 1990