510(k) K241626
K241626 is an FDA 510(k) premarket notification submitted by Ipreg Incorporation for the device "SperSort Sperm Sorting Chip (IPG02)". The FDA issued a decision of Substantially Equivalent on February 20, 2025. 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
- February 20, 2025
- Date Received
- June 6, 2024
- 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