510(k) clearance
Fertilis microICSI Device
- 510(k) number
- K262090
- Applicant
- Fertilis Pty, Ltd.
- Decision date
- Oct 9, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MQK
- Device type
- Labware, Assisted Reproduction
- Device class
- Class II
- Regulation
- 21 CFR 884.6160
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Adelaide, AU