Cleared Special

Endoscope Model EG-580UT and Endoscope Model EG-580UR

K221952 · Fujifilm Corporation · Gastroenterology & Urology

Aug 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K221952 is an FDA 510(k) clearance for the Endoscope Model EG-580UT and Endoscope Model EG-580UR, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on August 4, 2022, 30 days after receiving the submission on July 5, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K221952 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2022
Decision Date	August 04, 2022
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODG — Endoscopic Ultrasound System, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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).