The following data is part of a premarket notification filed by Med-sonics Corp with the FDA for Uretron Multiprobe Lithotripter System.
| Device ID | K160198 |
| 510k Number | K160198 |
| Device Name: | UreTron MultiProbe Lithotripter System |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | Med-Sonics Corp 4960 Pittsburgh Avenue Suite A Erie, PA 16509 |
| Contact | Jennifer Rautine |
| Correspondent | Jennifer Rautine Med-Sonics Corp 4960 Pittsburgh Avenue Suite A Erie, PA 16509 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854732006287 | K160198 | 000 |
| 00854732006126 | K160198 | 000 |
| 00854732006119 | K160198 | 000 |
| 00854732006102 | K160198 | 000 |
| 00854732006096 | K160198 | 000 |
| 00854732006089 | K160198 | 000 |
| 00854732006072 | K160198 | 000 |
| 00854732006065 | K160198 | 000 |
| 00854732006058 | K160198 | 000 |
| 00854732006041 | K160198 | 000 |
| 10854732006031 | K160198 | 000 |
| 00854732006027 | K160198 | 000 |
| 00854732006010 | K160198 | 000 |
| 00854732006140 | K160198 | 000 |
| 00854732006157 | K160198 | 000 |
| 00854732006270 | K160198 | 000 |
| 00854732006263 | K160198 | 000 |
| 00854732006256 | K160198 | 000 |
| 00854732006249 | K160198 | 000 |
| 00854732006232 | K160198 | 000 |
| 00854732006225 | K160198 | 000 |
| 00854732006218 | K160198 | 000 |
| 00854732006201 | K160198 | 000 |
| 00854732006195 | K160198 | 000 |
| 00854732006188 | K160198 | 000 |
| 00854732006171 | K160198 | 000 |
| 00854732006164 | K160198 | 000 |
| 00854732006003 | K160198 | 000 |