K083556 is an FDA 510(k) clearance for the MODIFICATION TO AUTO-BAND LIGATOR, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by Scandimed International (Jamestown, US). The FDA issued a Cleared decision on February 19, 2009, 79 days after receiving the submission on December 2, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K083556 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2008 |
| Decision Date | February 19, 2009 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MND — Ligator, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |