K964079 is an FDA 510(k) clearance for the SPEEDBAND MULTIPLE BAND LIGATOR. This device is classified as a Ligator, Hemorrhoidal (Class II - Special Controls, product code FHN).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 13, 1997, 125 days after receiving the submission on October 11, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K964079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1996 |
| Decision Date | February 13, 1997 |
| Days to Decision | 125 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 |