FFA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tube, Drainage, Suprapubic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2018: 35 · 2019: 26 · 2020: 14 · 2021: 24 · 2022: 17 · 2025: 27
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 |
|---|---|---|
| CATHETERS, BILIARY CATHETERS, UROLOGICAL (K944290) | Boston Scientific Corp | 1994-12-08 |
| SUCTION TUBE (K864770) | New England Surgical Instrument Corp. | 1987-02-24 |
| C-FLEX PENROSE DRAINAGE TUBE (K833061) | Concept, Inc. | 1983-11-07 |
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Every clearance here is in the API, with alerts when new ones post.