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U.S. Department of Health and Human Services

Product Classification

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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 CodeOTZ
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)
Regulation Number 886.4300
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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