Cleared Special

Seal Single-Use Biopsy Valve

K161167 · Endochoice, Inc. · Gastroenterology & Urology

May 2016

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K161167 is an FDA 510(k) clearance for the Seal Single-Use 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 May 26, 2016, 30 days after receiving the submission on April 26, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K161167 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2016
Decision Date	May 26, 2016
Days to Decision	30 days
Submission Type	Special
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.