Product areas
FDA product code distribution
Monteris Medical,
Country / region:United States (US)
510(k) submissions
11
Filtered: GEX
Latest clearance
2023-12-08
Product codes
1
GEX
510(k) submissions
11 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K231061 | NeuroBlate System | GEX | Class 2 | 2023-12-08 |
| K222983 | NeuroBlate Fusion-S Software V3.17 | GEX | Class 2 | 2023-03-15 |
| K201056 | NeuroBlate System | GEX | Class 2 | 2020-08-21 |
| K193375 | NeuroBlate System | GEX | Class 2 | 2020-01-03 |
| K182036 | NeuroBlate System | GEX | Class 2 | 2018-10-15 |
| K173305 | NeuroBlate System | GEX | Class 2 | 2017-11-17 |
| K172881 | NeuroBlate System | GEX | Class 2 | 2017-10-20 |
| K171255 | Monteris Medical NeuroBlate System | GEX | Class 2 | 2017-07-25 |
| K170724 | NeuroBlate System | GEX | Class 2 | 2017-04-07 |
| K162762 | NeuroBlate System | GEX | Class 2 | 2016-10-26 |
| K143457 | NeuroBlate System | GEX | Class 2 | 2015-02-19 |
Company profile
- Canonical name
- Monteris Medical,
- Aliases
- Monteris Medical, Inc., Monteris Medical Corp.
- Country
- United States(US)
Cited predicates
44- K182036
NeuroBlate System
- K211269
—
—
Not ingested - K214125
—
—
Not ingested - K222983
NeuroBlate Fusion-S Software V3.17
- K201056
NeuroBlate System
- K193375
NeuroBlate System
- K171255
Monteris Medical NeuroBlate System
- K193375
NeuroBlate System
- K182036
NeuroBlate System
- K171626
—
—
Not ingested - K163244
—
—
Not ingested - K182036
NeuroBlate System
- K173305
NeuroBlate System
- K172881
NeuroBlate System
- K173305
NeuroBlate System
- K171255
Monteris Medical NeuroBlate System
- K170724
NeuroBlate System
- K162762
NeuroBlate System
- K141983
—
—
Not ingested - K131955
—
—
Not ingested - K131278
—
—
Not ingested - K120561
—
—
Not ingested - K081509
—
—
Not ingested - K143457
NeuroBlate System
- K172881
NeuroBlate System
- K120561
—
—
Not ingested - K171255
Monteris Medical NeuroBlate System
- K170724
NeuroBlate System
- K162762
NeuroBlate System
- K143457
NeuroBlate System
- K141983
—
—
Not ingested - K131955
—
—
Not ingested - K131278
—
—
Not ingested - K081509
—
—
Not ingested - K170724
NeuroBlate System
- K162762
NeuroBlate System
- K162762
NeuroBlate System
- K143457
NeuroBlate System
- K141983
—
—
Not ingested - K120561
—
—
Not ingested - K120561
—
—
Not ingested - K141983
—
—
Not ingested - K143457
NeuroBlate System
- K141983
—
—
Not ingested
Monteris Medical, references 44 predicate/reference devices
Cited as predicate
25- K231061
NeuroBlate System
- K231061
NeuroBlate System
- K222983
NeuroBlate Fusion-S Software V3.17
- K222983
NeuroBlate Fusion-S Software V3.17
- K201056
NeuroBlate System
- K201056
NeuroBlate System
- K201056
NeuroBlate System
- K193375
NeuroBlate System
- K193375
NeuroBlate System
- K182036
NeuroBlate System
- K182036
NeuroBlate System
- K182036
NeuroBlate System
- K182036
NeuroBlate System
- K182036
NeuroBlate System
- K182036
NeuroBlate System
- K173305
NeuroBlate System
- K172881
NeuroBlate System
- K172881
NeuroBlate System
- K172881
NeuroBlate System
- K172881
NeuroBlate System
- K171255
Monteris Medical NeuroBlate System
- K171255
Monteris Medical NeuroBlate System
- K170724
NeuroBlate System
- K170724
NeuroBlate System
- K162762
NeuroBlate System
25 submissions cite Monteris Medical, as a predicate