K964111 is an FDA 510(k) clearance for the LITHOVAC SUCTION/ASPIRATION PROBE, a Evacuator, Gastro-urology (Class II — Special Controls, product code KQT), submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on December 16, 1996, 62 days after receiving the submission on October 15, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K964111 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1996 |
| Decision Date | December 16, 1996 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KQT — Evacuator, Gastro-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4370 |