Clamp, Eyelid, Ophthalmic
An Ophthalmic Eyelid Clamp is a surgical instrument used to grasp and stabilize the eyelid during procedures such as chalazion excision, lid repair, or other eyelid surgeries, providing hemostasis and secure tissue positioning. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HOD and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOD
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924774 | BURTON AUTOMATIC PROJECTOR - MODEL CP-40 | Apr 14, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K891610 | HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER | Jun 05, 1989 | Substantially Equivalent | Keeler Instruments, Inc. |
| K831285 | SURGICAL/LID MARGIN COVER & EYELASH- | Jun 03, 1983 | Substantially Equivalent | Richard R. Anthony, M.D. |
FEI Numbers
This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.