FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K Number: K150679
·
Decision May 29, 2015
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
49
Applicant Total
432
Review Days
73
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Basic Information
- Device Name
- EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
- K Number
- K150679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- March 17, 2015
- Decision Date
- May 29, 2015
- 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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