De Novo DEN150028
- Device
- PneumoLiner
- Contact
- edward hyland
- De Novo number
- DEN150028
- Product code
- PMU
- Regulation
- 884.4050
- Classification name
- containment system, laparoscopic power morcellation, with instrument port
- Decision
- granted (DENG)
- Decision date
- 2016-04-07
- Date received
- 2015-06-19
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct
Current FDA Classification#
- Product code
- PMU
- Device name
- Containment System, Laparoscopic Power Morcellation, With Instrument Port
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.4050
- Implant
- N
- Life sustain/support
- N