GBW
17 FDA 510(k) clearances · Product code
62 daysmedian time to decision
318 days90th percentile
17clearances measured
FDA profile
- Official device name
- Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2002: 1 · 2003: 2 · 2004: 4 · 2005: 2 · 2017: 21 · 2023: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Track GBW automatically
Every clearance here is in the API, with alerts when new ones post.