EVOENDO, INC.

FDA Device Registration & Listing · Grayslake, IL, US · Registration 3021691063

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021691063
FEI Number
3021691063
Entity Name
EVOENDO, INC.
City/State/Country
Grayslake, IL, US
Establishment Address
888 E Belvidere Rd Ste 212, Grayslake, IL 60030, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
EvoEndo, Inc. (Owner Number: 10084416)
Owner / Operator Contact Address
888 E Belvidere Rd, Suite 112, Grayslake, IL 60030, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251708
PMA Number
N/A

All Registered Proprietary Names

EvoEndo Single-Use Endoscopy System EvoEndo Single-Use Endoscopy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-02-18
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-02-18
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-11-15
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-11-15

Official Correspondent

Paul Imaoka

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EvoEndo, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K232314 FUJIFILM Healthcare Americas Corporation Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) 2023-09-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021691063. Last updated year: 2026. Please use registration number 3021691063 when referencing this establishment in official correspondence.
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