Cleared Traditional

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

K231249 · Pentax of America, Inc. · Gastroenterology & Urology

Jul 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K231249 is an FDA 510(k) clearance for the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL, 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 July 28, 2023, 88 days after receiving the submission on May 1, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K231249 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2023
Decision Date	July 28, 2023
Days to Decision	88 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.