Cleared Traditional

K040961 - INJECTOR NEEDLE/SNARE

K040961 is the FDA 510(k) clearance for INJECTOR NEEDLE/SNARE 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 86-day FDA review.

K040961 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jul 2004
Decision
86d
Days
Class 2
Risk

K040961 is an FDA 510(k) clearance for the INJECTOR NEEDLE/SNARE. 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 July 8, 2004 after a review of 86 days - a notably fast clearance 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: 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 United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K040961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2004
Decision Date July 08, 2004
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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 K040961.
ROTH NET RETRIEVER
K122462 · United States Endoscopy Group, Inc. · Sep 2012
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
K103611 · United States Endoscopy Group, Inc. · May 2011
ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · Ethicon Endo-Surgery, Inc. · Jun 2008
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · United States Endoscopy Group, Inc. · Mar 1997
OLYMPUS SD SERIES SNARES
K955650 · Olympus America, Inc. · Mar 1996
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K950496 · Boston Scientific Corp · Mar 1995