Cleared Traditional

ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS

K101298 · Endochoice, Inc. · Gastroenterology & Urology

Aug 2010

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K101298 is an FDA 510(k) clearance for the ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS, a Endoscopic Grasping/cutting Instrument, Non-powered (Class II — Special Controls, product code OCZ), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 5, 2010, 87 days after receiving the submission on May 10, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K101298 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2010
Decision Date	August 05, 2010
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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.