Definition: The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools.
| Device Type ID | 2845 |
| Device Name | Surgical Smoke Precipitator |
| Physical State | The Device Consists Of An Ion Delivery System And A Power Source. |
| Technical Method | The Device Is Introduced Into The Laparoscopic Site And Provides The Source Of The Ions That Charge The Surgical Smoke Particles And Facilitate Precipitation Of Surgical Smoke And Other Aerosolized Particulates |
| Target Area | The Device Is Intended For Laparoscopic Surgery Sites. |
| Regulation Description | Surgical Smoke Precipitator. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2845 |
| Device | Surgical Smoke Precipitator |
| Product Code | PQM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Smoke Precipitator. |
| CFR Regulation Number | 878.5050 [🔎] |
| Device Problems | |
|---|---|
Wireless Communication Problem | 4 |
Transmitter | 1 |
| Total Device Problems | 5 |