Cleared Traditional

iSnare system-Lariat

K152035 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Oct 2015

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K152035 is an FDA 510(k) clearance for the iSnare system-Lariat, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on October 15, 2015, 85 days after receiving the submission on July 22, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K152035 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2015
Decision Date	October 15, 2015
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FBK — Endoscopic Injection Needle, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.