OAB
14 FDA 510(k) clearances · Product code
179 daysmedian time to decision
336 days90th percentile
14clearances measured
FDA profile
- Official device name
- Low Energy Direct Current Thermal Ablation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- Ablation of soft tissue
- Adverse events (MAUDE)
- 2012: 82 · 2013: 17 · 2014: 18 · 2015: 11 · 2016: 9 · 2020: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Track OAB automatically
Every clearance here is in the API, with alerts when new ones post.