K093497 is an FDA 510(k) clearance for the THD BANDY, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on July 15, 2010, 245 days after receiving the submission on November 12, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K093497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2009 |
| Decision Date | July 15, 2010 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FHN — Ligator, Hemorrhoidal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |