K974018 is an FDA 510(k) clearance for the WILSON-COOK 10 SHOT MULTI-BAND LIGATOR. This device is classified as a Ligator, Hemorrhoidal (Class II - Special Controls, product code FHN).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 20, 1998, 90 days after receiving the submission on October 22, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K974018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1997 |
| Decision Date | January 20, 1998 |
| Days to Decision | 90 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 |