Definition: To Provide Selected Flow Rates And Pressures Of Co2 Gas To Separate Tissue Planes So The Saphenous Vein Or Radial Artery Can Be Isolated And Ligated.
| Device Type ID | 4072 |
| Device Name | Insufflator, Endoscopic Vessel Harvesting |
| Physical State | An Electronic Software Controlled Gas Insufflator Which Can Accept CO2 Gas From Either A Tank Or Central Wall Supply. The Gas Flow Rate And Pressure Can Be Adjusted By The User. |
| Technical Method | The Insufflator Delivers CO2 Gas At A Controlled Flow Rate And Pressure To Separate Tissue Planes So The Saphenous Vein Or Radial Artery Can Be Isolated And Ligated. |
| Target Area | Leg, Saphenous Vein Or Arm, Radial Artery |
| Regulation Description | Laparoscopic Insufflator. |
| 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 | 884.1730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4072 |
| Device | Insufflator, Endoscopic Vessel Harvesting |
| Product Code | OSV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laparoscopic Insufflator. |
| CFR Regulation Number | 884.1730 [🔎] |
| Device Problems | |
|---|---|
Environmental Particulates | 1 |
Mechanical Problem | 1 |
Bent | 1 |
Wire | 1 |
Device Remains Activated | 1 |
| Total Device Problems | 5 |