The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Cyberwand Sterile Probe Set.
| Device ID | K132795 |
| 510k Number | K132795 |
| Device Name: | CYBERWAND STERILE PROBE SET |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2013-11-26 |
| Summary: | summary |