| Device |
graft insertion instrument for endothelial keratoplasty |
| Regulation Description |
Intraocular lens guide. |
| 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. |
| 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 through the corneal incision in the subject's eye. Once in the eye, the operator can then releases or dispenses the tissue graft from the device. Following graft release, the graft insertion device is removed. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | OTZ |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.4300
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
