FRQ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tube, Levine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 1 · 2003: 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 |
|---|---|---|
| ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT (K914887) | Mallinckrodt Medical | 1992-05-08 |
| ICAN GT DRAINAGE BAG (K914530) | Icn Pharmaceuticals, Inc. | 1991-12-18 |
| PEDIWET=GUAZE IMPREGNATED WITH PETROL (K802007) | Pollak (Intl.), Ltd. | 1980-09-26 |
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Every clearance here is in the API, with alerts when new ones post.