K043116 is an FDA 510(k) clearance for the ICSI-100, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on January 13, 2005, 64 days after receiving the submission on November 10, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K043116 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 10, 2004 |
| Decision Date | January 13, 2005 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |