Cleared Traditional

K051637 - DSNARE, MODEL 00711087

K051637 is an FDA 510(k) clearance for DSNARE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCK cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K051637 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Oct 2005
Decision
133d
Days
Class 2
Risk

K051637 is an FDA 510(k) clearance for the DSNARE, 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 October 31, 2005 after a review of 133 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K051637

510(k) Number K051637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date October 31, 2005
Days to Decision 133 days
Submission Type Traditional
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
2d slower than avg
Panel avg: 131d · This submission: 133d
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 12
Devices cleared under the same product code (FCK) and FDA review panel - the closest regulatory comparables to K051637.
MULTIPLE BIOPSY SYSTEM
K103326 · United States Endoscopy Group, Inc. · Apr 2011
RB12 SUCTION RECTAL BIOPSY SYSTEM
K062159 · Aus Systems Pty , Ltd. · Sep 2006
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
K061201 · United States Endoscopy Group, Inc. · May 2006
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · United States Endoscopy Group, Inc. · Oct 1995
BIOPSY DEVICE ACCESSORY
K944252 · Biopsys Medical, Inc. · Dec 1994
SUCTION GUILLOTINE DEVICE
K932142 · Triton Technology, Inc. · Sep 1993
K051637 · DSNARE, MODEL 00711087
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