FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇨 Monaco
ENDOFLOW II - Irrigation, Warming and Suction System
K Number: K152278
·
Decision Feb 9, 2016
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
5
Review Days
181
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Basic Information
- Device Name
- ENDOFLOW II - Irrigation, Warming and Suction System
- K Number
- K152278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promepla Sam
- Date Received
- August 12, 2015
- Decision Date
- February 9, 2016
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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