FDA 510(k)
FDA class 2
Unknown
🇦🇺 Australia
CORIS System
K Number: DEN240018
·
Decision Mar 19, 2025
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
57
Applicant Total
3
Review Days
322
Basic Information
- Device Name
- CORIS System
- K Number
- DEN240018
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Nanosonics Limited
- Date Received
- May 1, 2024
- Decision Date
- March 19, 2025
- Product Code
- FEB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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