LEY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Set, Oral Administration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 1 · 1995: 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 |
|---|---|---|
| SET, ORAL ADMINISTRATION (K760251) | Cis Radiopharmaceuticals, Inc. | 1976-09-15 |
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Every clearance here is in the API, with alerts when new ones post.