510(k) DEN170075
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 19, 2017
- Date Received
- September 29, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- General Laparoscopic Power Morcellation Containment System
- Device Class
- Class II
- Regulation Number
- 878.4825
- Review Panel
- SU
- Submission Type
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.