Introducer, Sphere
A Sphere Introducer is an ophthalmic surgical instrument used to insert an ocular sphere implant into the eye socket following enucleation or evisceration, typically to maintain the volume of the orbit and support a prosthetic eye. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HNP and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNP
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.