K242968 is an FDA 510(k) clearance for the Giftlife? Single-Step Medium Plus, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 22, 2024, 57 days after receiving the submission on September 26, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K242968 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2024 |
| Decision Date | November 22, 2024 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |