K974796 is an FDA 510(k) clearance for the LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Medispec, Ltd. (Montgomery Village, US). The FDA issued a Cleared decision on March 12, 1998, 80 days after receiving the submission on December 22, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K974796 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 1997 |
| Decision Date | March 12, 1998 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| 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 |