K201001 is an FDA 510(k) clearance for the Modulith SLX-F2, a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II — Special Controls, product code LNS), submitted by Karl Storz Endoscopy America (Los Angeles, US). The FDA issued a Cleared decision on March 30, 2021, 348 days after receiving the submission on April 16, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K201001 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 16, 2020 |
| Decision Date | March 30, 2021 |
| Days to Decision | 348 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LNS — Lithotriptor, Extracorporeal Shock-wave, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5990 |