Cleared Traditional

K103611 - UROLOGY MONOPOLAR SNARE FOR TISSUE TRAN...

K103611 is the FDA 510(k) clearance for UROLOGY MONOPOLAR SNARE FOR TISSUE TRAN... by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K103611 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
151d
Days
Class 2
Risk

K103611 is an FDA 510(k) clearance for the UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 9, 2011 after a review of 151 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K103611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2010
Decision Date May 09, 2011
Days to Decision 151 days
Submission Type Traditional
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
21d slower than avg
Panel avg: 130d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FDI Snare, Flexible

All 36
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K103611.
MULTI-STAGE SNARE
K133513 · United States Endoscopy Group, Inc. · Dec 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K131700 · Boston Scientific Corp · Nov 2013
ROTH NET RETRIEVER
K122462 · United States Endoscopy Group, Inc. · Sep 2012
ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · Ethicon Endo-Surgery, Inc. · Jun 2008
INJECTOR NEEDLE/SNARE
K040961 · United States Endoscopy Group, Inc. · Jul 2004
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · United States Endoscopy Group, Inc. · Mar 1997