FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
Comaneci, Comaneci Petit, Comaneci 17
K Number: DEN170064
·
Decision Apr 24, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
3
Review Days
573
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Basic Information
- Device Name
- Comaneci, Comaneci Petit, Comaneci 17
- K Number
- DEN170064
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5955
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Rapid-Medical , Ltd.
- Date Received
- September 28, 2017
- Decision Date
- April 24, 2019
- Product Code
- PUU
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| PUU | Temporary Coil Embolization Assist Device | FDA class 2 | Neurology |