K182664 is an FDA 510(k) clearance for the FiXcision. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I - General Controls, product code KOA).
Submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on December 7, 2018, 73 days after receiving the submission on September 25, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K182664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOA - Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |