| Device Type ID | 1990 |
| Device Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Regulation Description | Extracorporeal Shock Wave Lithotripter. |
| 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 | 876.5990 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LNS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1990 |
| Device | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Product Code | LNS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extracorporeal Shock Wave Lithotripter. |
| CFR Regulation Number | 876.5990 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COMED MEDICAL SYSTEMS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DORNIER MEDTECH | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DORNIER MEDTECH AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 55 |
Unintended System Motion | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Fire | 1 |
Device Operates Differently Than Expected | 1 |
Unintended Movement | 1 |
Failure To Disconnect | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 64 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Medical Solutions USA, Inc | II | Nov-12-2015 |