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)
- K201213Pasteur Pipette 3mL, Pasteur Pipette 1mL2Cleared 510(K)
- K200815VitriGuard2Cleared 510(K)
- K181461Rapid-i™ Kit2Cleared 510(K)
- K181469Cryotop®US-flash and Cryotop®US-scoop2Cleared 510(K)
- K180740VitriGuard2Cleared 510(K)
- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)2Cleared 510(K)
- K172751iVitri Straw2Cleared 510(K)
- K162640iVitri EZ2Cleared 510(K)
- K162833VitriGuard2Cleared 510(K)
- K162051Cryotec2Cleared 510(K)
- K153027Cryotop US2Cleared 510(K)
- K150961EmbryoSlide Culture Dish2Cleared 510(K)
- K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-well2Cleared 510(K)
- K140207RAPID-I KIT2Cleared 510(K)
- K141663EEVA DISH (WITH 12 MICROWELLS)2Cleared 510(K)
- K133295QUALIS2Cleared 510(K)
- K140072CRYOTOP(R) SC2Cleared 510(K)
- K131145PROINSERT2Cleared 510(K)
- K122982CRYOLOCK2Cleared 510(K)
- K123641CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH2Cleared 510(K)
- K112644SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM2Cleared 510(K)
- K112695CRYOTOP2Cleared 510(K)
- K112413RI MSC (MIGRATION SEDIMENTATION CHAMBER)2Cleared 510(K)
- K103028EEVATM PETRI DISH2Cleared 510(K)
- K100596CRYOPETTE2Cleared 510(K)
- K092398HSV STRAW2Cleared 510(K)
- K090832RAPID-I2Cleared 510(K)
- K090429NUNC IVF CENTERWELL AND ICSI DISHES2Cleared 510(K)
- K081896BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH2Cleared 510(K)
- K080395SUNIVF DISHES2Cleared 510(K)
- K070047NUNC IVF DISHES AND NUNC IVF 4-WELL DISH2Cleared 510(K)
- K052457PICSI SPERM SELECTION DEVICE2Cleared 510(K)
- K040717NUNC IVF MULTIDISH 4 WELLS NUNCLON2Cleared 510(K)
- K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.752Cleared 510(K)
- K994361ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL2Cleared 510(K)
- K993881GENX CULTURE DISH2Cleared 510(K)
- K990941NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L2Cleared 510(K)
- K991249FALCON IVF FOUR WELL PLATE2Cleared 510(K)
- K991251FALCON IVF ONE WELL DISH2Cleared 510(K)
- K991253FALCON IVF ROUND DISH2Cleared 510(K)
- 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
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K112644
- 510(k) Type
- Traditional
- Applicant
- LOTUS BIO LTD
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/19/2012
- Days to Decision
- 464 days
- Submission Type
- Summary