FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Clear Guide SCENERGY
K Number: K153004
·
Decision Feb 12, 2016
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
6
Review Days
122
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Basic Information
- Device Name
- Clear Guide SCENERGY
- K Number
- K153004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clear Guide Medical
- Date Received
- October 13, 2015
- Decision Date
- February 12, 2016
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Clear Guide Medical
| K Number | Device Name | ||
|---|---|---|---|
| K234030 | Clear Guide SCENERGY | Jan 17, 2024 | Substantially Equivalent |
| K201188 | Clear Guide SCENERGY | Sep 30, 2020 | Substantially Equivalent |
| K201898 | Clear Guide SCENERGY | Jul 31, 2020 | Substantially Equivalent |
| K171677 | Clear Guide SCENERGY | Dec 8, 2017 | Substantially Equivalent |
| K141806 | CLEAR GUIDE ONE | Sep 19, 2014 | Substantially Equivalent |