K091519 is an FDA 510(k) clearance for the HAEMOBAND MULTI-LIGATOR. This device is classified as a Ligator, Hemorrhoidal (Class II - Special Controls, product code FHN).
Submitted by Haemoband Surgical, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on July 28, 2009, 67 days after receiving the submission on May 22, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K091519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2009 |
| Decision Date | July 28, 2009 |
| Days to Decision | 67 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 |