FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKOUT® system
K Number: K230658
·
Decision Apr 7, 2023
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
4
Review Days
29
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Basic Information
- Device Name
- SKOUT® system
- K Number
- K230658
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iterative Scopes, Inc.
- Date Received
- March 9, 2023
- Decision Date
- April 7, 2023
- Product Code
- QNP
- 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 |
|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | FDA class 2 | Gastroenterology, Urology |
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