Cleared Special

K061201 - DSNARE DIMINUTIVE POLYPECTOMY AND SUCTI...

K061201 is the FDA 510(k) clearance for DSNARE DIMINUTIVE POLYPECTOMY AND SUCTI... by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCK) cleared through the Special 510(k) pathway after a 29-day FDA review.

K061201 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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May 2006
Decision
29d
Days
Class 2
Risk

K061201 is an FDA 510(k) clearance for the DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087. Classified as Instrument, Biopsy, Suction (product code FCK), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 30, 2006 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K061201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date May 30, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Devices cleared under the same product code (FCK) and FDA review panel - the closest regulatory comparables to K061201.
Howell Biliary Aspiration Needle
K153763 · Wilson-Cook Medical, Inc. · Apr 2017
MULTIPLE BIOPSY SYSTEM
K103326 · United States Endoscopy Group, Inc. · Apr 2011
DSNARE, MODEL 00711087
K051637 · United States Endoscopy Group, Inc. · Oct 2005
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · United States Endoscopy Group, Inc. · Oct 1995
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · Wilson-Cook Medical, Inc. · Jan 1990