FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Entuit Start Initial Placement Gastrostomy Set
K Number: K170323
·
Decision Sep 14, 2017
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
175
Review Days
225
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Basic Information
- Device Name
- Entuit Start Initial Placement Gastrostomy Set
- K Number
- K170323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- February 1, 2017
- Decision Date
- September 14, 2017
- Product Code
- KGC
- 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 |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | FDA class 2 | Gastroenterology, Urology |
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