FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAR GUIDE ONE
K Number: K141806
·
Decision Sep 19, 2014
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
6
Review Days
78
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Basic Information
- Device Name
- CLEAR GUIDE ONE
- K Number
- K141806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clear Guide Medical
- Date Received
- July 3, 2014
- Decision Date
- September 19, 2014
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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| 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 |
| K153004 | Clear Guide SCENERGY | Feb 12, 2016 | Substantially Equivalent |