FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
K Number: K171040
·
Decision Jul 31, 2017
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
7
Review Days
116
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Basic Information
- Device Name
- Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K Number
- K171040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koelis
- Date Received
- April 6, 2017
- Decision Date
- July 31, 2017
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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Other Clearances by Koelis
| K Number | Device Name | ||
|---|---|---|---|
| K180970 | Disposable guides KDNG00 | Jul 10, 2018 | Substantially Equivalent |
| K170521 | TRINITY/3D PROSTATE SUITE | May 30, 2017 | Substantially Equivalent |
| K160357 | TRINITY | May 2, 2016 | Substantially Equivalent |
| K141334 | REUSABLE GUIDE | Jul 11, 2014 | Substantially Equivalent |
| K131448 | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION | Jul 26, 2013 | Substantially Equivalent |
| K100793 | UROSTATION 3D PROSTATE SUITE | Sep 22, 2010 | Substantially Equivalent |