K171024 is an FDA 510(k) clearance for the ShockPulse-SE Lithotripsy System, a Lithotriptor, Ultrasonic (Class II — Special Controls, product code FEO), submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on August 21, 2017, 138 days after receiving the submission on April 5, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K171024 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 2017 |
| Decision Date | August 21, 2017 |
| Days to Decision | 138 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 |