K031236 is an FDA 510(k) clearance for the AUTO-BAND LIGATOR, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by Scandimed. A.S. (Glostrop, DK). The FDA issued a Cleared decision on November 14, 2003, 210 days after receiving the submission on April 18, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K031236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2003 |
| Decision Date | November 14, 2003 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MND — Ligator, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |