HNC
11 FDA 510(k) clearances · Product code
18 daysmedian time to decision
103 days90th percentile
11clearances measured
FDA profile
- Official device name
- Specula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 2 · 1997: 7 · 1998: 5 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STEPHENS DISPOSABLE SPECULUM (K022836) | Stephens Instruments | 2002-11-01 |
| OCULOSTAT (K981235) | Laser Center Dev. Corp. | 1998-07-15 |
| EYE FIXATION SPECULUM (K964289) | Eyefix, Inc. | 1996-12-17 |
| 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 |
Track HNC automatically
Every clearance here is in the API, with alerts when new ones post.