FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
K Number: K244029
·
Decision Sep 24, 2025
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
1
Review Days
268
Basic Information
- Device Name
- ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- K Number
- K244029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endorobotics Co., Ltd.
- Date Received
- December 30, 2024
- Decision Date
- September 24, 2025
- Product Code
- FDF
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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