FSQ
7 FDA 510(k) clearances · Product code
87 daysmedian time to decision
236 days90th percentile
7clearances measured
FDA profile
- Official device name
- Light, Surgical, Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2004: 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 |
|---|---|---|
| LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT (K932139) | Aaron Medical Industries | 1993-07-30 |
| MIDMARK SURGICAL LIGHTING SYSTEMS (K930686) | Midmark Corp. | 1993-07-30 |
| ALM ILLUMINATOR SERIES LIGHT SYSTEM (K922409) | Alm Surgical Equipment, Inc. | 1993-01-12 |
| BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (K921848) | Alm Surgical Equipment, Inc. | 1992-10-01 |
| SURG-FLEX 10 LIGHT (K803067) | Medical Products Development, Inc. | 1981-02-26 |
| SURG-FLEX 15 SURGICAL LIGHT (K810019) | Medical Products Development, Inc. | 1981-01-23 |
| SURG-FLEX 5 SURGICAL LIGHT (K810018) | Medical Products Development, Inc. | 1981-01-23 |
Track FSQ automatically
Every clearance here is in the API, with alerts when new ones post.