Definition: A Graft Insertion Device For Endothelial Keratoplasty Is A Device Intended To Be Inserted Into The Eye During Surgery To Direct The Insertion Of A Corneal Graft And Be Removed After Insertion Is Completed.
| Device Type ID | 4401 |
| Device Name | Graft Insertion Instrument For Endothelial Keratoplasty |
| Physical State | Multiple Different Configurations May Exist: Similar To Intraocular Lens Guide/injector, Retractable Spatula, Multiple Component Systems, Etc. Design Is Meant To Specifically Deliver Corneal Graft Into Eye. |
| Technical Method | A Graft Insertion Device For Endothelial Keratoplasty Functions As A Protective Guide For The Insertion Of A Donor Corneal Graft Through A Corneal Incision. Once The Graft Tissue Has Been Loaded Into The Insertion Device, The Device Is Inserted Throu |
| Target Area | Eye |
| Regulation Description | Intraocular Lens Guide. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OTZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4401 |
| Device | Graft Insertion Instrument For Endothelial Keratoplasty |
| Product Code | OTZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Intraocular Lens Guide. |
| CFR Regulation Number | 886.4300 [🔎] |