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
- 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
- MQLMedia, Reproductive2Product Code
- K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium2Cleared 510(K)
- K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS2Cleared 510(K)
- K193285V-ONESTEP2Cleared 510(K)
- K192503GM501 Wash with Phenol Red and Gentamicin2Cleared 510(K)
- K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])2Cleared 510(K)
- K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium2Cleared 510(K)
- K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA2Cleared 510(K)
- K192845Sperm Freeze, Sperm Fridge2Cleared 510(K)
- K200680Synvitro Hyadase2Cleared 510(K)
- K192644GM501 SpermAir and GM501 SpermActive2Cleared 510(K)
- Show All 229 Submissions
- 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
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Prosthetic DevicesCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GM501 SpermAir and GM501 SpermActive
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192644
- 510(k) Type
- Traditional
- Applicant
- Hamilton Thorne Incorporated
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/23/2020
- Days to Decision
- 212 days
- Submission Type
- Summary