FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EvoEndo Single-Use Endoscopy System
K Number: K260573
·
Decision Apr 21, 2026
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
4
Review Days
60
Basic Information
- Device Name
- EvoEndo Single-Use Endoscopy System
- K Number
- K260573
- 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
- February 20, 2026
- Decision Date
- April 21, 2026
- 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 |
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