Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- MXQStent, Urethral, External Sphincter, Permanent3Product Code
- NAZStimulator, BladderFProduct Code
- NCVLithotripter, Shockwave (For Treating Gallbladder Stones)3Product Code
- EZZProsthesis, Vas Deferens3Product Code
- FAAReplacer, Urethral3Product Code
- FABReplacer, Ureteral3Product Code
- FACValve, Ureterovesicle3Product Code
- FAGProsthesis, Urethral Sphincter3Product Code
- FAODevice, Cystometric, Air3Product Code
- FBYCooler, Esophageal And Gastric3Product Code
- FBZCooler, Prostatic3Product Code
- LEIImplant, Anti-Gastroesophageal Reflux3Product Code
- LILMonitor, Penile TumescenceUProduct Code
- LJECatheter, NephrostomyUProduct Code
- LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUProduct Code
- LKXDevice, Thermal, HemorrhoidsUProduct Code
- LNLStimulator, Electrical For Sperm CollectionUProduct Code
- LNMAgent, Bulking, Injectable For Gastro-Urology Use3Product Code
- LNQIntestinal StimulatorFProduct Code
- LNRSystem, Photopheresis, Extracorporeal3Product Code
- LOADevice, Testicular Hypothermia3Product Code
- LQQColumns, Immunoadsorption In Extracorporeal Systems3Product Code
- LQSSpermatocele, AlloplasticUProduct Code
- LRLCushion, HemorrhoidUProduct Code
- LSTDevice, Erectile DysfunctionUProduct Code
- LTIImplant, Intragastric For Morbid Obesity3Product Code
- LXWColumn, Adsorption, Low Density, Lipoprotein3Product Code
- MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma3Product Code
- MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy3Product Code
- MERStent, Urethral, Prostatic, Permanent Or Semi-Permanent3Product Code
- MESStent, Urethral, Bulbous, Permanent Or Semi-Permanent3Product Code
- MIKDevice, Ultrasonic, Thermal Ablation3Product Code
- MIPImplanted Fecal Incontinence Device3Product Code
- MMYLipoprotein, Low Density, Removal3Product Code
- MOAAnalyzer, Diagnostic, Fiber Optic (Colon)3Product Code
- MRESolution, Sodium Hyaluronate3Product Code
- NZCStent, Urethral, Prostatic, Semi-Permanent3Product Code
- OAYLight Source System, Diagnostic Endoscopic3Product Code
- OCKTransurethral Occlusion Insert, Urinary Incontinence-Control, Female3Product Code
- ODHImplantable Bladder-Evacuation Electrical Stimulation SystemFProduct Code
- OKNHyperthermia System, Bladder Cancer Treatment, With Chemotherapy3Product Code
- OVLHemodialyzer, High Cut-OffFProduct Code
- OYFAspiration Therapy System3Product Code
- PATBladder SystemFProduct Code
- PAZElectrical Stimulation Bladder SystemFProduct Code
- PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsFProduct Code
- PDIBeta 2-Microglobulin Apheresis ColumnFProduct Code
- PFEGastrointestinal Liner SystemNProduct Code
- PHNProtective Coating, Mucoadhesive Application, For The Rectal MucosaUProduct Code
- PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs3Product Code
- PIKMetabolic Neuromodulation SystemNProduct Code
- PIMNeuromodulator For Obesity3Product Code
- PMHMechanical Compression Device Fecal Incontinence (Non-Manually Operated)FProduct Code
- QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation3Product Code
- QLOImmunoadsorption Column For Emergency UseNProduct Code
- QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health EmergenNProduct Code
- QNBPlasma Processing System For Converting Alpha To Pre-Beta High-Density LipoproteinFProduct Code
- QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation3Product Code
- QRHCatheter, Balloon, Urethral, Drug-Coated3Product Code
- QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence3Product Code
- QSWEndoscopic Traction Device2Product Code
- QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss2Product Code
- QTHEndoscopic Light-Projecting Measuring Device2Product Code
- QTNOrally Ingested Transient Device For Constipation2Product Code
- QUDBlood Detection Capsule2Product Code
- QUNTether Accessory For Use In The Gastrointestinal Tract2Product Code
- QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.2Product Code
- QXHGallbladder Drainage Stent And Delivery System2Product Code
- QXMImplanted Tibial Electrical Urinary Continence Device2Product Code
- QEJFlushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries2Product Code
- QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia3Product Code
- QZFGastrointestinal Capsule Endoscopy Analysis Software Device2Product Code
- SAKSoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis2Product Code
- SCBDeflation Needle For Removal Of Intragastric Balloon2Product Code
- QNAUltrasonic Urinary Stone Propulsion Device2Product Code
- SDQAlfapump System3Product Code
- SDKTransdermal Test For Assessment Of Glomerular Filtration Rate3Product Code
- SFWCranial Electrotherapy Stimulator For Weight Management1Product Code
- Submissions with No Product CodeMiscellaneous
- K243175Disposable Intermittent Catheter (TPU Catheter)Cleared 510(K)
- K243079NeuroTrac® MyoPlus Pro (MYO120U)Cleared 510(K)
- K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Cleared 510(K)
- K870757OTOLOGICAL METRIC SCALE/GAUGECleared 510(K)
- K863236ACUSON S519B TRANSDUCERCleared 510(K)
- K861905PLOTTER MODEL (MP100)Cleared 510(K)
- K853741INDONTINENCE PADCleared 510(K)
- K852913HGM ENDOCOAGULATOR MODEL 20Cleared 510(K)
- K851319DIALYSIS CONCENTRATECleared 510(K)
- K852104MANAN PTC BIOPSY TRAYSCleared 510(K)
- P920051STORZ MODULITH (TM) LITHOTRIPTERAPRLPMA Approval
- P920051STORZ MODULITH (TM) LITHOTRIPTERAPRLPMA Approval
- K850393FLEXIBLE FIBEROPTIC ENDOSCOPECleared 510(K)
- K841104ENTERNAL FEEDING PUMP BATTERY OPER.Cleared 510(K)
- K850186POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &Cleared 510(K)
- K844478HEARING AIDS MODELS IMS, ISD, ICL & IHXCleared 510(K)
- K842001LIVER BIOPSY TRAYCleared 510(K)
- K842212MICROMEDICS SURGICAL INSTRUMENTSCleared 510(K)
- K841350SALIVARY BYPASS TUBECleared 510(K)
- K842342MWI 888 & 666 DOUBLE LUMEN SUBCLAVIANCleared 510(K)
- K841348UMBRELLA KEELCleared 510(K)
- K841668CO2 LAPAROSCOPECleared 510(K)
- K840709MID-STREAM URINE COLLECTION SETSCleared 510(K)
- K841179HEMO-KARTCleared 510(K)
- K841178ALU-KARTCleared 510(K)
- K841180DIA-KARTCleared 510(K)
- K840743REDY 2000Cleared 510(K)
- K840266K-FLEX OSTOMY POUCHCleared 510(K)
- K832560ASPIRATING HANDLE W/BACKFLUSHING CAPABCleared 510(K)
- K830527N.E.W. NEBCleared 510(K)
- K823748EXPANDED PTFE PROSTHESIS BLOOD ACCESCleared 510(K)
- K8229141424 TUMISTORECleared 510(K)
- K822849RAAF DUAL LUMEN CATHETERCleared 510(K)
- K823075REXTONCleared 510(K)
- K822267TRANSFORMERCleared 510(K)
- K821821PERCUTANEOUS TRACHEOSTOMY DEVICECleared 510(K)
- K821508RIONET HEARING AIDCleared 510(K)
- K821414MODEL 80 BCCleared 510(K)
- K821130PEDIATRIC URINE COLLECTORCleared 510(K)
- K820125COBE CENTRY 2000 RXCleared 510(K)
- K810708HOLLISTER MALE URINARY INCONT. SYSTEMCleared 510(K)
- K803109URISTOPCleared 510(K)
- K802187STERILE DISPOSABLE CYTOLOGY BRUSHCleared 510(K)
- K791857HOLLOW FIBER DIALIZER MODEL TRIEX-3Cleared 510(K)
- K790902INTEGRATED PATIENT STATIONSCleared 510(K)
- K790779MODEL H39C-BEHING-THE-EAR HEARING INSTRUCleared 510(K)
- K790352NEPHROSS 11F100Cleared 510(K)
- K781215TEST MODULE MODEL DM-352Cleared 510(K)
- K772347PHONIC MIRROR HANDIVOICE MODEL 120Cleared 510(K)
- K772346PHONIC MIRROR HANDIVOCIE MODEL 110Cleared 510(K)
- K770879BRONCHOFIBERSCOPE, FB-19ACleared 510(K)
- K770402RADIOEAR MODEL 1072Cleared 510(K)
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
REDY 2000
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K840743
- 510(k) Type
- Traditional
- Applicant
- ORGANON TEKNIKA CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent - PostMarket Surveillance Required
- Decision Date
- 2/6/1984
- Days to Decision
- 0 days