SperSort Sperm Sorting Chip (IPG02)— 510(k) K241626
Substantially EquivalentIpreg Incorporation
FDA 510(k) clearance K241626 for SperSort Sperm Sorting Chip (IPG02), Substantially Equivalent on 2025-02-20. Applicant: Ipreg Incorporation. Device class: 2.
Clearance details
- Applicant
- Ipreg Incorporation
- Product code
- 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
- New Taipei City, TW
Recent devices under product code MQK
view all- K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241341 — cryo-GO Vitrification Device
- K240002 — G-Vitri Vitrification Straw
- K232980 — SpermAlign Sperm Separation Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.