FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smith+Nephew INTELLIO Tablet
K Number: K221929
·
Decision Sep 6, 2022
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
17
Applicant Total
1
Review Days
67
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Basic Information
- Device Name
- Smith+Nephew INTELLIO Tablet
- K Number
- K221929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith+Nephew
- Date Received
- July 1, 2022
- Decision Date
- September 6, 2022
- Product Code
- ODA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| ODA | Endoscopic Central Control Unit | FDA class 2 | Gastroenterology, Urology |
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