The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Cyberwand Dual Action Ultrasonic Lithotripsy System.
| Device ID | K120303 |
| 510k Number | K120303 |
| Device Name: | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CYBERSONICS, INC. 5325 KUHL RD. Erie, PA 16510 |
| Contact | Lori Colvin |
| Correspondent | Lori Colvin CYBERSONICS, INC. 5325 KUHL RD. Erie, PA 16510 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-01 |
| Decision Date | 2012-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855279005320 | K120303 | 000 |
| H891CWUSLFS2 | K120303 | 000 |
| H891CWUSLG2 | K120303 | 000 |
| H891CWUSLNC2 | K120303 | 000 |
| H891CWUSLPC2 | K120303 | 000 |
| H891CWUSLSA4 | K120303 | 000 |
| H891CWUSLTA2 | K120303 | 000 |
| H891CWUSLW2 | K120303 | 000 |
| 00855279005009 | K120303 | 000 |
| 00855279005283 | K120303 | 000 |
| 00855279005306 | K120303 | 000 |
| 00855279005313 | K120303 | 000 |
| H891CWRBPBX3 | K120303 | 000 |