Data / Medical devices / United States / Evoendo, Inc.
Evoendo, Inc.: FDA-registered device maker in Grayslake, IL, United States, 2 510(k) clearances
Evoendo, Inc. is registered with the FDA (registration 3021691063) in Grayslake, IL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021691063
- Address
- 888 E Belvidere Rd Ste 212, Grayslake, IL, United States, 60030
- Owner or operator
- EvoEndo, Inc. (10084416)
- Roles
- Specification developer
- First device listed
- February 18, 2022
- Registered through
- 2026
- Brand names listed
- EvoEndo Single-Use Endoscopy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Specification developer | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2025 | K251708 | EvoEndo Single-Use Endoscopy System | FDS | Substantially Equivalent | EvoEndo, Inc. | accessdata.fda.gov |
| February 14, 2022 | K213606 | EvoEndo Single-Use Endoscopy System | FDS | Substantially Equivalent | EvoEndo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.