# EvoEndo, Inc.

- Location (FDA's records): Grayslake, IL
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Product codes: FDS (4)
- 510(k) review time since 2016: median 83 days, against 211 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujinon, Inc.: 1 (https://510kreport.com/company/fujinon)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K213606: EvoEndo Single-Use Endoscopy System (2022), cited by 2
- K251708: EvoEndo Single-Use Endoscopy System (2025), cited by 1

## Recent decisions
- K260573: EvoEndo Single-Use Endoscopy System (Apr 21, 2026)
- K251708: EvoEndo Single-Use Endoscopy System (Oct 10, 2025)
- K250900: EvoEndo Single-Use Endoscopy System (Jun 16, 2025)
- K213606: EvoEndo Single-Use Endoscopy System (Feb 14, 2022)

Source page: https://510kreport.com/company/evoendo