FCH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tray, Biopsy, Without Biopsy Instruments
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1993: 1 · 2000: 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 |
|---|---|---|
| SIGMA 1 WOBBLER BIOPSY KIT (K882673) | Kontron Instruments, Inc. | 1988-07-28 |
| MANAN UBK ULTRASONIC GUIDED BIOPSY KIT (K852105) | Manan Manufacturing Co., Inc. | 1985-06-18 |
Track FCH automatically
Every clearance here is in the API, with alerts when new ones post.