Cleared Traditional

BIOPSY VALVE

K111821 · Endochoice, Inc. · Gastroenterology & Urology

Jul 2011

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K111821 is an FDA 510(k) clearance for the BIOPSY VALVE, a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 28, 2011, 30 days after receiving the submission on June 28, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K111821 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2011
Decision Date	July 28, 2011
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.