FEA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Attachment, Teaching, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2022: 16 · 2023: 21
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 |
|---|---|---|
| JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER (K935247) | Jedmed Instrument Co. | 1994-02-18 |
| AO TEACHING ATTACHMENT, MODEL TA-1 (K791635) | American Optical Corp. | 1979-09-24 |
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Every clearance here is in the API, with alerts when new ones post.