K240307 is an FDA 510(k) clearance for the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH). This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2024, 196 days after receiving the submission on February 2, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K240307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2024 |
| Decision Date | August 16, 2024 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF - Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |