K240434 is an FDA 510(k) clearance for the RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6). This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II - Special Controls, product code HHK).
Submitted by Li Medical Corporation , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on September 25, 2024, 224 days after receiving the submission on February 14, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K240434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2024 |
| Decision Date | September 25, 2024 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHK - Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1175 |