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 [🔎] |