Graft Insertion Instrument For Endothelial Keratoplasty
The Graft Insertion Instrument for Endothelial Keratoplasty (product code OTZ) is an ophthalmic surgical instrument inserted into the eye during keratoplasty surgery to direct the insertion of a corneal graft and then removed after insertion is completed. It is used in endothelial keratoplasty procedures such as DSEK or DMEK to facilitate precise delivery of donor corneal tissue. As an FDA Class 1 device under regulation 886.4300, it is subject only to general controls, the lowest FDA regulatory tier. It falls within the Ophthalmic specialty and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OTZ
- Device Class
- FDA class 1
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203586 | EndoSerter-PL | Feb 02, 2022 | Substantially Equivalent | Corneagen, Inc. |
| K121579 | EK DELIVERY DEVICE | Oct 03, 2012 | Substantially Equivalent | Tdak Medical, Inc. |
| K110734 | NCI SPATULA | May 31, 2012 | Substantially Equivalent | Fischer Surgical, Inc. |
| K102999 | TRIMOTION INJECTOR | Dec 29, 2011 | Substantially Equivalent | Kaneka Corp. |
| K090626 | ENDOSERTER | Jan 21, 2011 | Substantially Equivalent | Ocular Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.