The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Shock Pulse-se Lithotripsy System Cyberwand Ii.
| Device ID | K142428 |
| 510k Number | K142428 |
| Device Name: | Shock Pulse-SE Lithotripsy System CYBERWAND II |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | CYBERSONICS, INC. 5340 Fryling Road Erie, PA 16510 |
| Contact | Jeff Vaitekunas |
| Correspondent | Jeff Vaitekunas CYBERSONICS, INC. 5340 Fryling Road Erie, PA 16510 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2014-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855279005160 | K142428 | 000 |
| 00855279005016 | K142428 | 000 |
| 00855279005023 | K142428 | 000 |
| 00855279005030 | K142428 | 000 |
| 00855279005054 | K142428 | 000 |
| 00855279005061 | K142428 | 000 |
| 00855279005092 | K142428 | 000 |
| 00855279005108 | K142428 | 000 |
| 10855279005129 | K142428 | 000 |
| 00855279005139 | K142428 | 000 |
| 00855279005153 | K142428 | 000 |
| 00821925039445 | K142428 | 000 |