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510(k) K242640

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin by Fertipro NV — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2025
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Fertipro NV

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  • K053494 — OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE (March 23, 2006)

Other clearances for product code MQL

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  • K251305 — Ultra-Fast Vitri; Ultra-Fast Warm (August 26, 2025)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)
  • K241095 — ARTSMedia Semen Wash Medium (December 18, 2024)