Cleared Special

KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE

K111165 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology

Jan 2012

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K111165 is an FDA 510(k) clearance for the KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE, a Endoscopic Central Control Unit (Class II — Special Controls, product code ODA), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 6, 2012, 255 days after receiving the submission on April 26, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K111165 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2011
Decision Date	January 06, 2012
Days to Decision	255 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODA — Endoscopic Central Control Unit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.