| Device Type ID | 1790 |
| Device Name | Lithotriptor, Ultrasonic |
| Regulation Description | Electrohydraulic Lithotriptor. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4480 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FEO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1790 |
| Device | Lithotriptor, Ultrasonic |
| Product Code | FEO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrohydraulic Lithotriptor. |
| CFR Regulation Number | 876.4480 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CYBERSONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EMS ELECTRO MEDICAL SYSTEMS SA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Break | 11 |
Material Integrity Problem | 5 |
Material Separation | 4 |
Material Fragmentation | 3 |
Probe | 3 |
Difficult To Remove | 3 |
Improper Or Incorrect Procedure Or Method | 1 |
Delivered As Unsterile Product | 1 |
Device Displays Incorrect Message | 1 |
Metal Shedding Debris | 1 |
Temperature Problem | 1 |
Device Damaged By Another Device | 1 |
| Total Device Problems | 35 |