FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synergetics PHOTON EX
K Number: K143123
·
Decision Feb 24, 2015
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
39
Applicant Total
1
Review Days
116
Basic Information
- Device Name
- Synergetics PHOTON EX
- K Number
- K143123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synergetics
- Date Received
- October 31, 2014
- Decision Date
- February 24, 2015
- Product Code
- MPA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPA | Endoilluminator | FDA class 2 | Gastroenterology, Urology |
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