| Device Type ID | 3658 |
| Device Name | Device, Surgical, Cryogenic |
| Regulation Description | Cryogenic Surgical Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3658 |
| Device | Device, Surgical, Cryogenic |
| Product Code | GXH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cryogenic Surgical Device. |
| CFR Regulation Number | 882.4250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATRICURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MYOSCIENCE INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Tear, Rip Or Hole In Device Packaging | 4 |
Human-Device Interface Problem | 1 |
No Apparent Adverse Event | 1 |
Device Handling Problem | 1 |
User Interface | 1 |
Scratched Material | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Myoscience Inc | II | Jul-22-2015 |