Definition: Intended For Use As A Bag Containment System By Qualified Surgeons For Tissue Extraction And/or Power Morcellation During General Laparoscopic Procedures.
| Device Type ID | 5904 |
| Device Name | General Laparoscopic Power Morcellation Containment System |
| Physical State | A Retractor And Boot Assembly With A Tissue Pouch/specimen Bag. |
| Technical Method | A Tissue Pouch Is Placed Through A Multi-instrument Port To Allow For Containment Of Tissue. The Pouch Is Insufflated To Create A Working Space For Morcellation. A Laparoscopic Power Morcellator And A Laparoscope Are Placed Through The Port And Into |
| Target Area | Abdomen |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4825 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5904 |
| Device | General Laparoscopic Power Morcellation Containment System |
| Product Code | PZQ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4825 [🔎] |