Product areas
FDA product code distribution
Dawell Medical, LLC
Country / Region:United States (US)
510(k) submissions
1
Filtered: GEX
Latest clearance
2025-10-14
Product codes
1
GEX
Cited as predicate
0
510(k) submissions
1 total · filtered by GEX
Showing 1–1
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K250776 | Lithoblast Single Use Holmium Laser Fibers | GEX | Class 2 | 2025-10-14 |
Company profile
- Canonical name
- Dawell Medical, LLC
- Country / Region
- United States(US)
Predicate manufacturers
Companies whose devices this company cited as predicates
1 manufacturers
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
No citing manufacturers yet
Other companies will appear here when they cite this company's devices as predicates