FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
More-Cell-System
K Number: K212659
·
Decision Nov 10, 2021
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
4
Review Days
79
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Basic Information
- Device Name
- More-Cell-System
- K Number
- K212659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4050
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agency For Medical Innovations GmbH
- Date Received
- August 23, 2021
- Decision Date
- November 10, 2021
- Product Code
- PMU
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port | FDA class 2 | Obstetrics/Gynecology |
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