Definition: Minimally Invasive Devices With The Means To Penetrate Soft Tissue To Access The Abdomen. The Attachment And The Shaft Will Be Assembled And Disassembled Within The Abdomen Before And After Use. The Devices Are Used To Grasp, Hold, And Manipulate Sof
| Device Type ID | 5853 |
| Device Name | Percutaneous Surgical Set With Attachments |
| Physical State | A Shaft Plus End Effector Attachments With Different Sizes |
| Technical Method | A Shaft Of The Device That Can Penetrate Through Soft Tissue; Attachments That Will Be Delivered Through A Traditional Conduit (such As A Trocar) And Assembled With The Shaft Inside The Abdomen. |
| Target Area | Abdominal Region |
| 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 | 878.4805 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OXT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5853 |
| Device | Percutaneous Surgical Set With Attachments |
| Product Code | OXT |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4805 [🔎] |