Cleared Special

PENTAX Medical Video Duedenoscope ED34-i10T2

K210710 · Pentax of America, Inc. · Gastroenterology & Urology

Apr 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K210710 is an FDA 510(k) clearance for the PENTAX Medical Video Duedenoscope ED34-i10T2, a Duodenoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDT), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on April 9, 2021, 30 days after receiving the submission on March 10, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K210710 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2021
Decision Date	April 09, 2021
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FDT — Duodenoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).