Cleared Special

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

K163424 · United State Endoscopy Group, Inc. · Gastroenterology & Urology

Jan 2017

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K163424 is an FDA 510(k) clearance for the AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by United State Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 4, 2017, 29 days after receiving the submission on December 6, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K163424 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2016
Decision Date	January 04, 2017
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement