FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EvoEndo Single-Use Endoscopy System
K Number: K251708
·
Decision Oct 10, 2025
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
4
Review Days
129
Basic Information
- Device Name
- EvoEndo Single-Use Endoscopy System
- K Number
- K251708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EvoEndo, Inc.
- Date Received
- June 3, 2025
- Decision Date
- October 10, 2025
- Product Code
- FDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDS), ordered by most recent decision date.
EvoEndo Single-Use Endoscopy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Distal Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology