K150718 is an FDA 510(k) clearance for the Wi-3 HAL-RAR System. This device is classified as a Ligator, Hemorrhoidal (Class II - Special Controls, product code FHN).
Submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on June 12, 2015, 85 days after receiving the submission on March 19, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K150718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2015 |
| Decision Date | June 12, 2015 |
| Days to Decision | 85 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 |