HNL
10 FDA 510(k) clearances · Product code
35 daysmedian time to decision
84 days90th percentile
10clearances measured
FDA profile
- Official device name
- Probe, Lachrymal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1999: 2 · 2001: 2 · 2002: 2 · 2003: 1 · 2006: 4 · 2014: 6
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 |
|---|---|---|
| CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491) | Concept, Inc. | 1984-10-05 |
| TSE-ANDERSON MODIFIED LACRIMAL GROOV (K840861) | Hansen Ophthalmic Development Lab | 1984-05-09 |
| STERILE OIL AND GUIDEWIRE (K833671) | CooperVision, Inc. | 1984-01-10 |
| LACIMAL INTUBATION SETS (K831901) | Visitec Co. | 1983-07-12 |
| PILLING LACRIMAL INTUBATION SYSTEM (K813187) | Narco Scientific | 1982-01-28 |
| ETHICON LACRIMAL STENT (K812255) | ETHICON, Inc. | 1981-08-20 |
| CONCEPT CANALICULUS INTUBATION SET (K802845) | Concept, Inc. | 1980-12-17 |
| JACKSON LACRIMAL INTUBATION SET (K801232) | Storz Instrument Co. | 1980-06-17 |
| CRAWFORD LACRIMAL INTUBATION SET (K800089) | Jedmed Instrument Co. | 1980-03-03 |
| NASO-LACRIMAL DUCT INSERT (K770194) | Concept, Inc. | 1977-02-14 |
Track HNL automatically
Every clearance here is in the API, with alerts when new ones post.