EYE FIXATION SPECULUM
FDA 510(k) clearance K964289 · decided 1996-12-17
Clearance details
- K-number
- K964289
- Device name
- EYE FIXATION SPECULUM
- Applicant
- Eyefix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-28
- Decision date
- 1996-12-17
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HNC
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STEPHENS DISPOSABLE SPECULUM (K022836) | Stephens Instruments | 2002-11-01 |
| OCULOSTAT (K981235) | Laser Center Dev. Corp. | 1998-07-15 |
| THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (K863989) | Keeler Instruments, Inc. | 1986-10-31 |
| OPHTHALMIC SURGICAL SPECULUM (K863664) | Myocure, Inc. | 1986-09-25 |
| VISITEC EYE SPECULUM (K843196) | Visitec Co. | 1984-10-05 |
| EYELID SPECULUM (K830430) | Douglas C. Mckee & Co. | 1983-06-10 |
| ASNIS GUIDED SCREW SYSTEMS (K801969) | Howmedica Corp. | 1980-08-27 |
| FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (K760847) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (K760849) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (K760848) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
Recalls involving this device
No recalls on record reference this clearance.