Specula, Ophthalmic
The Ophthalmic Specula are eyelid retractors used to hold the eyelids open during ophthalmic examinations or surgical procedures, allowing unobstructed access to the ocular surface and anterior segment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HNC, 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
- HNC
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022836 | STEPHENS DISPOSABLE SPECULUM | Nov 01, 2002 | Substantially Equivalent | Stephens Instruments |
| K981235 | OCULOSTAT | Jul 15, 1998 | Substantially Equivalent | Laser Center Dev. Corp. |
| K964289 | EYE FIXATION SPECULUM | Dec 17, 1996 | Substantially Equivalent | Eyefix, Inc. |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Oct 31, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Sep 25, 1986 | Substantially Equivalent | Myocure, Inc. |
| K843196 | VISITEC EYE SPECULUM | Oct 05, 1984 | Substantially Equivalent | Visitec Co. |
| K830430 | EYELID SPECULUM | Jun 10, 1983 | Substantially Equivalent | Douglas C. Mckee & Co. |
| K801969 | ASNIS GUIDED SCREW SYSTEMS | Aug 27, 1980 | Substantially Equivalent | Howmedica Corp. |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | Nov 02, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | Nov 02, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | Nov 02, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 190 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 190 registration numbers. Click on an entry to view related FDA registrations.