Fertilis microICSI Device— 510(k) K262090
Substantially EquivalentFertilis Pty, Ltd.
FDA 510(k) clearance K262090 for Fertilis microICSI Device, Substantially Equivalent on 2026-10-09. Applicant: Fertilis Pty, Ltd.. Device class: 2.
Summary
The Fertilis microICSI Device is filed under MQK, assisted reproduction labware. Beyond the name, the record doesn't describe the device's form or how it's used.
Class II, 21 CFR 884.6160. The Obstetrics/Gynecology panel reviewed it as a Traditional 510(k).
Fertilis filed from Adelaide, Australia. The review clock ran 109 days, from June 22 to October 9, 2026.
Clearance details
- Applicant
- Fertilis Pty, Ltd.
- Product code
- Product code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Adelaide, AU
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Data sourced from openFDA. This site is unofficial and independent of the FDA.