K070881 is an FDA 510(k) clearance for the LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Sapimed S.P.A. (Crofton, US). The FDA issued a Cleared decision on September 26, 2007, 180 days after receiving the submission on March 30, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K070881 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2007 |
| Decision Date | September 26, 2007 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHN — Ligator, Hemorrhoidal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |