Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- K241626SperSort™ Sperm Sorting Chip (IPG02)2Cleared 510(K)
- K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)2Cleared 510(K)
- K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)2Cleared 510(K)
- K241341cryo-GO Vitrification Device2Cleared 510(K)
- K240002G-Vitri™ Vitrification Straw2Cleared 510(K)
- K232980SpermAlign Sperm Separation Device2Cleared 510(K)
- K233177Nest VT Vitrification Device2Cleared 510(K)
- K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device2Cleared 510(K)
- K213869EmbryoSlide+ ic8 dish2Cleared 510(K)
- K203626SureStrip Vitrification Straw, SureLock Vitrification Straw2Cleared 510(K)
Show All 50 Submissions
- MQLMedia, Reproductive2Product Code
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- QUJAutomated Cryopreservation Storage System2Product Code
- QYZAt Home Intravaginal Insemination System2Product Code
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K241348
- 510(k) Type
- Traditional
- Applicant
- MotilityCount ApS
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/31/2025
- Days to Decision
- 263 days
- Submission Type
- Summary