510(k) K262090
K262090 is an FDA 510(k) premarket notification submitted by Fertilis Pty, Ltd. for the device "Fertilis microICSI Device". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2026
- Date Received
- Jun 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type
- 510(k)