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
- K242684Harioculture TL-16 Time-lapse Incubator2Cleared 510(K)
- K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)2Cleared 510(K)
- K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish2Cleared 510(K)
- K173264EmbryoScope+2Cleared 510(K)
- K180304Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K171736Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K160753COOK Vacuum Pump2Cleared 510(K)
- K160504RI Witness Embryology Heated Plate2Cleared 510(K)
- K151357MIRI TL2Cleared 510(K)
- K133712EMBRYOVIEWER SOFTWARE2Cleared 510(K)
- K132870Origio Gas Line Filter2Cleared 510(K)
- K133742XQ-1 INCUBATOR2Cleared 510(K)
- K121566PLANER BT37 INCUBATOR2Cleared 510(K)
- K113075EMBRYO VIEWER SOFTWARE2Cleared 510(K)
- K111715EMBRYOSCOPE2Cleared 510(K)
- K101988HEAL FORCE CO2 INCUBATOR2Cleared 510(K)
- K092183EMBRYOSCOPE AND EMBRYOSLIDE2Cleared 510(K)
- K050197MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 20452Cleared 510(K)
- K041952ZIVF-AIRE2Cleared 510(K)
- K032086KRYO ART CONTROLLED RATE FREEZER2Cleared 510(K)
- K032526BINDER CO2 INCUBATOR SERIE CB2Cleared 510(K)
- K030525CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES2Cleared 510(K)
- K023465KENDRO HERACELL 240 INCUBATOR2Cleared 510(K)
- K011327DB1 EMBRYO FREEZE2Cleared 510(K)
- K020560WORKBENCH BY <GENX>2Cleared 510(K)
- K021042THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,74762Cleared 510(K)
- K014160PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)2Cleared 510(K)
- K013703SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M2Cleared 510(K)
- K013401K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-012Cleared 510(K)
- K002971MTG - MINITUB HEATED STAGE SYSTEMS2Cleared 510(K)
- K001600<GENX> CODA INCUBATOR CELLMATE2Cleared 510(K)
- K002961MINITUB MULTI-PURPOSE CASSETTES2Cleared 510(K)
- K003184RS BIOTECH GALAXY 'R' CO2 INCUBATOR2Cleared 510(K)
- K002595CBS STRAW2Cleared 510(K)
- K002805KENDRO HERACELL CO2 INCUBATOR2Cleared 510(K)
- K001486GENX CODA AIR PURIFICATION SYSTEM2Cleared 510(K)
- K001524FORMA SCIENTIFIC DIRECT HEAT INCUBATORS2Cleared 510(K)
- K000394CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT2Cleared 510(K)
- K992070COOK ULTRA QUIET VACUUM PUMP & REGULATOR2Cleared 510(K)
- K991216HOFFMAN IVF-12Cleared 510(K)
- K991408FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR2Cleared 510(K)
- K991263THERMOPLATE2Cleared 510(K)
- K991229K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L2Cleared 510(K)
- K983642COOK MINI-INCUBATOR2Cleared 510(K)
- K983609COOK TEST TUBE HEATER2Cleared 510(K)
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- 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
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K013401
- 510(k) Type
- Traditional
- Applicant
- K-Systems, Kivex Biotec , Ltd.
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/14/2001
- Days to Decision
- 60 days
- Submission Type
- Statement