Definition: To Approximate Soft Tissues By Means Of Absorbable Staples Delivered Via A Pre-loaded Stapler Delivery System For Use During Nasal Septal Surgery, With Or Without Cartilage Reinserted. To Connect Internal Nasal Tissues To Aid Healing During Nasal Sep
| Device Type ID | 1648 |
| Device Name | Septal Stapler/absorbable Staples |
| Physical State | Resorbable Polymer (e.g., Poly(L-lactide-co-glycolide) With A Size Of Approximately 5 Mm X 2.5 Mm X 0.5 Mm Thick. |
| Technical Method | Resorbable Fixation Devices Are Delivered Via A Pre-loaded Manual Surgical Stapler Delivery System. |
| Target Area | Nasal Septum. |
| Regulation Description | Implantable Staple. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1648 |
| Device | Septal Stapler/absorbable Staples |
| Product Code | OLL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Staple. |
| CFR Regulation Number | 878.4750 [🔎] |