Cleared Traditional

EvoEndo Single-Use Endoscopy System

K250900 · EvoEndo, Inc. · Gastroenterology & Urology

Jun 2025

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K250900 is an FDA 510(k) clearance for the EvoEndo Single-Use Endoscopy System, a Gastroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDS), submitted by EvoEndo, Inc. (Grayslake, US). The FDA issued a Cleared decision on June 16, 2025, 83 days after receiving the submission on March 25, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K250900 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2025
Decision Date	June 16, 2025
Days to Decision	83 days
Submission Type	Traditional
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).