FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENFit to ENFit Extension Sets
K Number: K230326
·
Decision Nov 2, 2023
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
49
Applicant Total
1
Review Days
269
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Basic Information
- Device Name
- ENFit to ENFit Extension Sets
- K Number
- K230326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vesco Medical
- Date Received
- February 6, 2023
- Decision Date
- November 2, 2023
- Product Code
- PIF
- 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 |
|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
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