Cleared Traditional

ENDOSCOPIC RETRIEVAL DEVICE

K120084 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

May 2012

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K120084 is an FDA 510(k) clearance for the ENDOSCOPIC RETRIEVAL DEVICE, a Endoscopic Grasping/cutting Instrument, Non-powered (Class II — Special Controls, product code OCZ), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 30, 2012, 140 days after receiving the submission on January 11, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K120084 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2012
Decision Date	May 30, 2012
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	OCZ — Endoscopic Grasping/cutting Instrument, Non-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.