General Laparoscopic Power Morcellation Containment System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4825
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.