FBW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Filiform And Filiform Follower
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5520
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1999: 6 · 2000: 4 · 2004: 3 · 2018: 14 · 2023: 17 · 2026: 56
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 |
|---|---|---|
| LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE (K912839) | Baxter Healthcare Corp | 1991-09-25 |
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Every clearance here is in the API, with alerts when new ones post.