NXTHERA
NXTHERA appears in FDA public data with 1 recall, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0262-2018, Class II) was initiated on July 28, 2017. Its most recent 510(k) clearance was granted on February 27, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0262-2018 | Class II | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Sui | July 28, 2017 |