Cleared Special

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

K212296 · Fujifilm Corporation · Gastroenterology & Urology

Aug 2021

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K212296 is an FDA 510(k) clearance for the Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2, a Gastroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDS), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on August 19, 2021, 28 days after receiving the submission on July 22, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K212296 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2021
Decision Date	August 19, 2021
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FDS — Gastroscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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).