Definition: Use As A Multiple Instrument Port And Tissue Containment System During Minimally Invasive Gynecologic Laparoscopic Surgery To Enable The Isolation And Containment Of Tissue Considered Benign, Resected During Single-port Or Multi-site Laparoscopic Sur
| Device Type ID | 4084 |
| Device Name | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| 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 Resected Gynecologic Tissue. The Pouch Is Insufflated To Create A Working Space For Morcellation. A Laparoscopic Power Morcellator And A Laparoscope Are Placed Throu |
| Target Area | Abdomen |
| Regulation Description | Gynecologic Laparoscopic Power Morcellation Containment System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4084 |
| Device | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Product Code | PMU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gynecologic Laparoscopic Power Morcellation Containment System. |
| CFR Regulation Number | 884.4050 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 1 |
Break | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 4 |