Needle, Ophthalmic Suturing
An Ophthalmic Suturing Needle is a specialized needle used in eye surgery to pass suture material through delicate ocular tissues such as the cornea, sclera, conjunctiva, or extraocular muscles during repair or reconstructive procedures. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification or approval. It carries product code HNM and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNM
- 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 80 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.