FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K Number: K180622
·
Decision Oct 23, 2018
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
130
Review Days
228
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Basic Information
- Device Name
- Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
- K Number
- K180622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- March 9, 2018
- Decision Date
- October 23, 2018
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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