K142428 is an FDA 510(k) clearance for the Shock Pulse-SE Lithotripsy System CYBERWAND II, a Lithotriptor, Ultrasonic (Class II — Special Controls, product code FEO), submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on November 13, 2014, 76 days after receiving the submission on August 29, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K142428 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 29, 2014 |
| Decision Date | November 13, 2014 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEO — Lithotriptor, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4480 |