Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- 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
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- K243011Silicone Urethral Catheter (Silicone Urethral Catheter)2Cleared 510(K)
- K241424InnoCare Specialty Foley Catheter2Cleared 510(K)
- K232469Rüsch Latex Gold Foley Catheter2Cleared 510(K)
- K240057TraumaGuard Intra-abdominal Pressure Sensing System2Cleared 510(K)
- K233411Folysil Silicone Catheter2Cleared 510(K)
- K2330132-Way 100% Silicone Cleartract Catheter2Cleared 510(K)
- K212077Teleflex Rusch SoftSimplastic Foley Catheters2Cleared 510(K)
- K231101Flume Catheter2Cleared 510(K)
- K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F2Cleared 510(K)
- K2221182-Way 100% Silicone Cleartract Catheter2Cleared 510(K)
- K2216252-Way 100% Silicone ClearTract Catheter2Cleared 510(K)
- K212151FLUME catheter2Cleared 510(K)
- K202134Well Lead All Silicone Foley Catheter with Temperature Sensor2Cleared 510(K)
- K201776Foley Balloon Catheter for Urology2Cleared 510(K)
- K202698Prefilled Syringe2Cleared 510(K)
- K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc2Cleared 510(K)
- K200556AquaFlate Pre-Filled Sterile Water Syringe 10mL2Cleared 510(K)
- K182463Silicone Foley Catheter2Cleared 510(K)
- K190060Urethrotech UCD2Cleared 510(K)
- K182635Signal Catheter2Cleared 510(K)
- K181616PSM 3-Way Silicone Foley Catheter2Cleared 510(K)
- K180781Bard Vertus Foley Catheter2Cleared 510(K)
- K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water2Cleared 510(K)
- K173657Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter2Cleared 510(K)
- K181346CystoSure Plus Catheter2Cleared 510(K)
- K173340Yikang Latex Foley Catheter2Cleared 510(K)
- K172807Silicone Foley Catheter for single use2Cleared 510(K)
- K173533Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter2Cleared 510(K)
- K172422Kohli Urinary Drainage Catheter2Cleared 510(K)
- K161770Rusch Silicone Foley Catheter2Cleared 510(K)
- K162989Rusch Simplastic Foley Catheters2Cleared 510(K)
- K153655Accuryn Monitoring System2Cleared 510(K)
- K150550SilverCoat Silicone Foley Catheter2Cleared 510(K)
- K150699Bard LubriGuard Foley Catheter2Cleared 510(K)
- K142635Medline Silicone Foley Catheter2Cleared 510(K)
- K140667WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER2Cleared 510(K)
- K140099LIGHTHOUSE URINARY CATHETER2Cleared 510(K)
- K131655LIGHTHOUSE(TM) URINARY CATHETER2Cleared 510(K)
- K130908DISPOSABLE SILICONE FOLEY CATHETER2Cleared 510(K)
- K131020TEMPERATURE SENSOR CATHETER2Cleared 510(K)
- K110214DIRECTVISION CATHETER, UNCOATED2Cleared 510(K)
- K103371COUDE/ OR TIEMANN2Cleared 510(K)
- K101824AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER2Cleared 510(K)
- K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR2Cleared 510(K)
- K0917673 WAY SILICONE FOLEY BALLOON CATHETER2Cleared 510(K)
- K091699AMSURE HYDROPHILIC LATEX FOLEY CATHETER2Cleared 510(K)
- K090262PERCUCATH URINARY CATHETER2Cleared 510(K)
- K082919UC-CARE POSITIONING SYSTEM2Cleared 510(K)
- K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERS2Cleared 510(K)
- K070582BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS2Cleared 510(K)
- K070558BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS2Cleared 510(K)
- K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR2Cleared 510(K)
- K071423MEDLINE LATEX FOLEY CATHETER2Cleared 510(K)
- K062112SUNMED FOLEY CATHETERS2Cleared 510(K)
- K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR2Cleared 510(K)
- K070508BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR2Cleared 510(K)
- K052168MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.2Cleared 510(K)
- K053429ADVANCED UROLOGICAL CATHETER2Cleared 510(K)
- K051059AMSURE 100% SILICONE FOLEY CATHETER2Cleared 510(K)
- K042110BEAMCATH2Cleared 510(K)
- K042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER2Cleared 510(K)
- K041983OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA390162Cleared 510(K)
- K040504BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS2Cleared 510(K)
- K033830OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA10002Cleared 510(K)
- K030120AMSURE FOLEY CATHETER2Cleared 510(K)
- K031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES2Cleared 510(K)
- K024010DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER2Cleared 510(K)
- K030813PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND2Cleared 510(K)
- K021939VITALCARE FOLEY CATHETER2Cleared 510(K)
- K023090OPTION-VF URINARY CATHETER, FV142182Cleared 510(K)
- K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 48652Cleared 510(K)
- K0222873T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS2Cleared 510(K)
- K002612BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON2Cleared 510(K)
- K013276ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)2Cleared 510(K)
- K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,2Cleared 510(K)
- K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL2Cleared 510(K)
- K010006DRAINAGE CATHETER OR FOLEY CATHETER2Cleared 510(K)
- K003784MENTOR SELF-CATH PLUS2Cleared 510(K)
- K003289BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU2Cleared 510(K)
- K002868BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER2Cleared 510(K)
- K993063RUSCH BRILLANT SILICONE FOLEY2Cleared 510(K)
- K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C2Cleared 510(K)
- K990509OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #338182Cleared 510(K)
- K984084BARDEX LUBRI-SIL FOLEY CATHETER2Cleared 510(K)
- K982970MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER2Cleared 510(K)
- K973076EUROMEDICAL HAEMATURIA FOLEY CATHETER2Cleared 510(K)
- K982626URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH02Cleared 510(K)
- K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER2Cleared 510(K)
- K980870RUSCH SILICONE FOLEY CATHETER2Cleared 510(K)
- K980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER2Cleared 510(K)
- K974419RUSCH SIMPLASTIC COUNCILL TIP CATHETER2Cleared 510(K)
- K972184RUSCH BRILLANT SILICONE FOLEY CATHETER2Cleared 510(K)
- K971643RUSCH BRILLANT BALLOON CATHETER2Cleared 510(K)
- K971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS2Cleared 510(K)
- K971801LAPAROTOMY BLADDER NECK SUSPENSION KIT2Cleared 510(K)
- K964757CONTIDRAIN CATHETER2Cleared 510(K)
- K970716OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE2Cleared 510(K)
- K964575SYMPACATH HYDROGEL COATED FOLEY2Cleared 510(K)
- K961697OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE2Cleared 510(K)
- K944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE2Cleared 510(K)
- K944676MRI'S ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K954752PEDIATRIC EUROPHYLIC FOLEY CATHETER2Cleared 510(K)
- K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETER2Cleared 510(K)
- K951106SILICONE FOLEY CATHETER2Cleared 510(K)
- K951103SILASTIC BRAND FOLEY CATHETER2Cleared 510(K)
- K945806SILICATH ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K941692FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER2Cleared 510(K)
- K944382ORION ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K944380ORION FOLEY CATHETER2Cleared 510(K)
- K944381ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE2Cleared 510(K)
- K944376ORION ALL SILICONE ELASTOMER COATED CATHETER2Cleared 510(K)
- K941488DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER2Cleared 510(K)
- K934895GLASSMAN SILICONE CATHETER2Cleared 510(K)
- K935630NORTA2Cleared 510(K)
- K930344SILICONE FOLEY CATHETER2Cleared 510(K)
- K932809FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR2Cleared 510(K)
- K911617UROTECH CATHETER2Cleared 510(K)
- K922821YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES2Cleared 510(K)
- K921561YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES2Cleared 510(K)
- K905042COMFORT SLEEVED ALL SILICONE FOLEY CATHETER2Cleared 510(K)
- K903777WRP FOLEYCATH2Cleared 510(K)
- K902710FOLEY CATHETER2Cleared 510(K)
- K894883PHYCON ALL SILICONE BALLOON CATHETER2Cleared 510(K)
- K810691CURITY 100% SILICONE IRRIGATION FOLEY2Cleared 510(K)
- K780062CATHETER/HEMOSTATIC/GERIATRIC2Cleared 510(K)
- K772218CATHETER, SILICONE COATED2Cleared 510(K)
- K771860FOLHY CATHETER2Cleared 510(K)
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- 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
Well Lead All Silicone Foley Catheter with Temperature Sensor
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K202134
- 510(k) Type
- Special
- Applicant
- Well Lead Medical Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/8/2021
- Days to Decision
- 251 days
- Submission Type
- Summary