Eye Fixation Speculum
FDA 510(k) K964289 · Eyefix, Inc.
510(k) numberK964289
Submission
- Device name
- Eye Fixation Speculum
- Applicant
- Eyefix, Inc.
Rockville, MD, US - Received
- October 28, 1996
- Decision date
- December 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HNC – Specula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022836 | Stephens Disposable SpeculumHNC · Traditional | Stephens Instruments | 11/01/2002SE |
| K981235 | OculostatHNC · Traditional | Laser Center Dev. Corp. | 07/15/1998SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863664 | Ophthalmic Surgical SpeculumHNC · Traditional | Myocure, Inc. | 09/25/1986SE |
| K843196 | Visitec Eye SpeculumHNC · Traditional | Visitec Co. | 10/05/1984SE |
| K830430 | Eyelid SpeculumHNC · Traditional | Douglas C. Mckee & Co. | 06/10/1983SE |
| K801969 | Asnis Guided Screw SystemsHNC · Traditional | Howmedica Corp. | 08/27/1980SE |
| K760849 | Feldstein Blepharostomy Clip SquareHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760848 | Feldstein Blepharoplasty Clip RectanguHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760847 | Feldstein Blepharoplasty Clip Sharp PHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
Questions and answers
When was Eye Fixation Speculum cleared by the FDA?
Eye Fixation Speculum (K964289) received a 510(k) decision of Substantially Equivalent on December 17, 1996, 50 days after the submission was received.
What is the product code of K964289?
The FDA product code is HNC – Specula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.