K243821 is an FDA 510(k) clearance for the i-Cut. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by A.M.I. Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on April 25, 2025, 134 days after receiving the submission on December 12, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K243821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET - Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |