Cleared Traditional

K151197 - Lariat snare

K151197 is the FDA 510(k) clearance for Lariat 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 62-day FDA review.

K151197 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
62d
Days
Class 2
Risk

K151197 is an FDA 510(k) clearance for the Lariat 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 6, 2015 after a review of 62 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 K151197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2015
Decision Date July 06, 2015
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 K151197.
Rotatable Snares, Non-Rotatable Snares
K172758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2018
Single Use Electrosurgical Snare SD-400
K172734 · Olympus Medical Systems Corp. · Dec 2017
Rotatable Snares
K160637 · Boston Scientific Corporation · Mar 2016
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
K140726 · Boston Scientific Corp · Jul 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · Boston Scientific Corporation · Jan 2014
MULTI-STAGE SNARE
K133513 · United States Endoscopy Group, Inc. · Dec 2013