FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sidecar External Working Channel
K Number: K150083
·
Decision Apr 14, 2015
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- Sidecar External Working Channel
- K Number
- K150083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C2 Therapeutics
- Date Received
- January 15, 2015
- Decision Date
- April 14, 2015
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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