Retractor, Ophthalmic
An Ophthalmic Retractor is a manual surgical instrument used to hold back eyelid margins, conjunctiva, or other ocular tissues to provide the surgeon with clear access to the surgical field during eye operations. This device is FDA Class 1 (lowest risk), subject only to general controls and does not require premarket notification or approval. It carries product code HNI and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNI
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 158 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 158 registration numbers. Click on an entry to view related FDA registrations.