GBC
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lamp, Surgical, Incandescent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 1
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 |
|---|---|---|
| HALUX EXLITE MINOR SURGERY LIGHT (K896961) | Jedmed Instrument Co. | 1990-02-22 |
| FLAT SUCTION DRAIN (K830610) | Sil-Med Corp. | 1983-03-29 |
| SKYTRON ELITE SURGICAL TABLES (K811311) | Skytron, Div. the Kmw Group, Inc. | 1981-06-02 |
| MINOR SURGERY LIGHT (K810207) | Cavitron Corp. | 1981-02-13 |
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Every clearance here is in the API, with alerts when new ones post.