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
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K250776 | Lithoblast Single Use Holmium Laser Fibers | GEX | Class 2 | 2025-10-14 |
Company profile
- Canonical name
- Dawell Medical, LLC
- Country
- United States(US)
Cited predicates
1- K170366
Laser Peripherals, LLC Family of Bare Laser Fibers
Dawell Medical, LLC references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list Dawell Medical, LLC as a predicate