HNQ
10 FDA 510(k) clearances · Product code
34 daysmedian time to decision
133 days90th percentile
10clearances measured
FDA profile
- Official device name
- Hook, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1999: 4 · 2000: 1 · 2001: 1 · 2003: 1 · 2018: 15 · 2024: 16
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 |
|---|---|---|
| OPHTEC ENCLAVATION NEEDLE (K030471) | Ophtec, USA | 2003-04-17 |
| STEPHENS DISPOSABLE HOOKS (K022842) | Stephens Instruments | 2002-11-01 |
| PRISMA DISPOSABLE IRRIGATING IRIS HOOK (K874991) | Advanced Surgical Products, Inc. | 1988-04-13 |
| LOOK LENS LOOPS (K870440) | Look, Inc. | 1987-02-20 |
| DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY (K864292) | Eye-Ko, Inc. | 1986-12-29 |
| THORTON TITANIUM HOOK ANGLED RIGHT (K863988) | Keeler Instruments, Inc. | 1986-10-31 |
| BONN MICRO IRIS HOOK (NON-STERILE) #7613 (K801469) | Edward Weck, Inc. | 1980-07-28 |
| HOOKS #'S 7600,7602,7603,7616 (K791985) | Edward Weck, Inc. | 1979-10-04 |
| HOOK, IRIS, SHEPARD U-SHAPED (K770103) | Edward Weck, Inc. | 1977-01-25 |
| HOOK, IRIS, HERSHMAN (K770098) | Edward Weck, Inc. | 1977-01-24 |
Track HNQ automatically
Every clearance here is in the API, with alerts when new ones post.