Submission Details
| 510(k) Number | K081142 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2008 |
| Decision Date | May 16, 2008 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
AUTO-BAND LIGATOR
May 2008
Decision
24d
Days
Class 2
Risk
About This 510(k) Submission
K081142 is an FDA 510(k) clearance for the AUTO-BAND LIGATOR, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by Scandimed International (Glostrop, DK). The FDA issued a Cleared decision on May 16, 2008, 24 days after receiving the submission on April 22, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
Device Classification
| Product Code | MND — Ligator, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |
Manufacturer
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