K052135 is an FDA 510(k) clearance for the CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on December 20, 2005, 137 days after receiving the submission on August 5, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K052135 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 2005 |
| Decision Date | December 20, 2005 |
| Days to Decision | 137 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4480 |