Cleared Traditional

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

K190805 · Pentax of America, Inc. · Gastroenterology & Urology

Dec 2019

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K190805 is an FDA 510(k) clearance for the PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL, a Endoscope, Accessories, Image Post-processing For Color Enhancement (Class II — Special Controls, product code PEA), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on December 20, 2019, 266 days after receiving the submission on March 29, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K190805 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2019
Decision Date	December 20, 2019
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PEA — Endoscope, Accessories, Image Post-processing For Color Enhancement
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.