K012746 is an FDA 510(k) clearance for the ICE BATON. This device is classified as a Device, Thermal, Hemorrhoids.
Submitted by Behive, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on November 14, 2001, 90 days after receiving the submission on August 16, 2001.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K012746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2001 |
| Decision Date | November 14, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKX — Device, Thermal, Hemorrhoids |
| Device Class | — |