OTZ — Graft Insertion Instrument For Endothelial Keratoplasty Class I
FDA product code OTZ covers "Graft Insertion Instrument For Endothelial Keratoplasty", a Class I medical device regulated under 21 CFR 886.4300. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTZ
- Device Class
- Class I
- Regulation Number
- 886.4300
- Submission Type
- 510(k)
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.