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Graft Insertion Instrument For Endothelial Keratoplasty

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
886.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4300 Intraocular lens guide

§ 886.4300 Intraocular lens guide.

(a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

(b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]

Graft Insertion Instrument For Endothelial Keratoplasty

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
886.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4300 Intraocular lens guide

§ 886.4300 Intraocular lens guide.

(a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

(b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]