FDA 510(k)
FDA class 2
Unknown
🇮🇪 Ireland
PneumoLiner
K Number: DEN150028
·
Decision Apr 7, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
3
Review Days
293
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Basic Information
- Device Name
- PneumoLiner
- K Number
- DEN150028
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 884.4050
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Advanced Surgical Concepts, Ltd.
- Date Received
- June 19, 2015
- Decision Date
- April 7, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PMU), ordered by most recent decision date.
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