Spoon, Ophthalmic
The Ophthalmic Spoon is a small, smooth, spoon-shaped surgical instrument used in ophthalmic procedures such as lens extraction (particularly in extracapsular cataract surgery) or to maneuver delicate ocular tissues during surgery. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without a premarket notification submission. The product code is HNB, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HNB
- 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 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.