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
- FADStent, Ureteral2Product Code
- K243039Ureteral Stents (AF-D series)2Cleared 510(K)
- K243830Disposable ureteral stent2Cleared 510(K)
- K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set2Cleared 510(K)
- K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm2Cleared 510(K)
- K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg2Cleared 510(K)
- K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits2Cleared 510(K)
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm2Cleared 510(K)
- K213186NovoFlow Reinforced Ureteral Stent2Cleared 510(K)
- K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KIT2Cleared 510(K)
- K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System2Cleared 510(K)
- K201436Vortek Single Loop Ureteral Stent2Cleared 510(K)
- K191446Ureteral Stent Systems, Biliary Drainage Catheters2Cleared 510(K)
- K190659Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip2Cleared 510(K)
- K190312Dornier Ureteral Stent2Cleared 510(K)
- K191609Tria Soft Ureteral Stent2Cleared 510(K)
- K190603Tria Firm Ureteral Stent2Cleared 510(K)
- K181971Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set2Cleared 510(K)
- K180557Greene Renal Transplant Stent Set2Cleared 510(K)
- K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent2Cleared 510(K)
- K180216Seidmon Antegrade AQ Stent Set2Cleared 510(K)
- K180029Malecot Nephrostomy Catheter/Stent Set2Cleared 510(K)
- K180053Sof-Flex Ureteral Stent Set2Cleared 510(K)
- K171603Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set2Cleared 510(K)
- K172017Black Silicone Filiform Double Pigtail Stent Set2Cleared 510(K)
- K173734RocaJJ Soft Stents2Cleared 510(K)
- K180057VORTEK URETERAL DOUBLE LOOP STENT2Cleared 510(K)
- K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS2Cleared 510(K)
- K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS2Cleared 510(K)
- K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent2Cleared 510(K)
- K170010Salle Intraoperative Pyeloplasty Stent Set2Cleared 510(K)
- K163399Tria Firm Ureteral Stent2Cleared 510(K)
- K162109Kwart Retro-Inject Ureteral Stent2Cleared 510(K)
- K162104C-Flex Ureteral Stent Set2Cleared 510(K)
- K161236Universa Firm Ureteral Stents and Stent Sets2Cleared 510(K)
- K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent2Cleared 510(K)
- K161277ConvertX Nephroureteral Stent System2Cleared 510(K)
- K160891Ultrathane Endoureterotomy Stent Set2Cleared 510(K)
- K151051Universa Soft Ureteral Stents and Stent Sets2Cleared 510(K)
- K141344EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM2Cleared 510(K)
- K082805PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX2Cleared 510(K)
- K072293FOSSA URETERAL OPEN STENTS2Cleared 510(K)
- K063742RESONANCE METALLIC URETERAL STENT2Cleared 510(K)
- K060673PEDIATRIC URETERAL STENT2Cleared 510(K)
- K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET2Cleared 510(K)
- K043193BARD INLAYOPTIMA URETERAL STENT WITH SUTURE2Cleared 510(K)
- K040760MODIFICATION TO URETERAL STENT2Cleared 510(K)
- K031292MODIFICATION TO FOSSA URETERAL STONE SWEEPER2Cleared 510(K)
- K030503MODIFICATION TO CONTOUR POLARIS URETERAL STENT2Cleared 510(K)
- K022447BARD ER URETERAL STENT WITH SUTURE2Cleared 510(K)
- K013921PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X2Cleared 510(K)
- K013784URETERAL STENT2Cleared 510(K)
- K021602FOSSA URETERAL STONE SWEEPER2Cleared 510(K)
- K021140FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT2Cleared 510(K)
- K011264MESH URETERAL STENT2Cleared 510(K)
- K010002CONTOUR POLARIS URETERAL STENT2Cleared 510(K)
- K992391UROSURGE SPIRALFLO URETERAL STENT2Cleared 510(K)
- K982974DD URETERAL STENT, INTEGRAL STENT2Cleared 510(K)
- K991219C-FLEX URETERAL STENTS2Cleared 510(K)
- K983498BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE2Cleared 510(K)
- K981591VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT2Cleared 510(K)
- K981491UROSURGE FILASTENT URETERAL STENT2Cleared 510(K)
- K981489UROSURGE SPIRASTENT PLUS URETERAL STENT2Cleared 510(K)
- K974541MODIFIED URETERAL INDWELLING CATHETER/STENT2Cleared 510(K)
- K973504UROSURGE UROSTENT2Cleared 510(K)
- K961371SUBCUTANEOUS URINARY DIVERSON STENT SET2Cleared 510(K)
- K952513LESE STENTS SETS2Cleared 510(K)
- K961446AQ HYDROPHILIC STENT2Cleared 510(K)
- K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT2Cleared 510(K)
- K946296QUADRA-COIL URETERAL STENT2Cleared 510(K)
- K930731SLIP-COAT STENTS2Cleared 510(K)
- K941952SURGITEK INFUSER2Cleared 510(K)
- K933941MENLO CARE URINARY DIVERSION STENT2Cleared 510(K)
- K923394MENLO CARE AQUASTENT SET2Cleared 510(K)
- K930733URETERAL STENT2Cleared 510(K)
- K930882UROLOGICAL CATHETER & ACCESSORIES2Cleared 510(K)
- K925282UROLOGICAL CATHETER AND ACCESSORIES2Cleared 510(K)
- K920695URETERAL STENT2Cleared 510(K)
- K914280ECHOSIGHT STENT SET2Cleared 510(K)
- K913928SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT2Cleared 510(K)
- K912060MENTOR BLACK LIGHT INJECTION STENT SET2Cleared 510(K)
- K910691NORTEC URETERAL STENT2Cleared 510(K)
- K903345BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE2Cleared 510(K)
- K905505VAS-CATH URETERAL STENTS CATHETER, MODIFICATION2Cleared 510(K)
- K905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT2Cleared 510(K)
- K904231MODEL OSP, SANDHILL AMS2Cleared 510(K)
- K894357VAS-CATH URETERAL STENT CATHETER2Cleared 510(K)
- K883561BARD(R) URETERAL STENT W/SUTURE2Cleared 510(K)
- K882157PANAMEX(TM) URETERAL STENT2Cleared 510(K)
- K881744PORGES URETERAL STENT2Cleared 510(K)
- K880660SURGITEK SUPER DOUBLE J URETERAL STENT KIT2Cleared 510(K)
- K875038MENTOR UNISTENT URETERAL STENT SET2Cleared 510(K)
- K873557MENTOR BLACK LIGHT URETERAL STENT SET2Cleared 510(K)
- K872353SURGITEK INFUSION STENT SYSTEM*2Cleared 510(K)
- K871667URETERAL STENT2Cleared 510(K)
- K871291AM CATH ESWL STENT2Cleared 510(K)
- K865085KAMINSKY COMBINATION STENT & INJECTION CATHETER2Cleared 510(K)
- K864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT2Cleared 510(K)
- K864669AM CATH ESWL STENT2Cleared 510(K)
- K863492METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.2Cleared 510(K)
- K862539SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE2Cleared 510(K)
- K861478BARD DOUBLE PIGTAIL URETERAL STENT2Cleared 510(K)
- K860267MARDIS DANGLER URETERAL STENT SET2Cleared 510(K)
- K854908UROFLEX2Cleared 510(K)
- K860055MENTOR SINGLE COIL URINARY DIVERSION STENT SET2Cleared 510(K)
- K854862CURITY URETERAL STENT2Cleared 510(K)
- K852389URETERAL STENT2Cleared 510(K)
- K851870MENTOR UNIVERSAL URETERAL STENT SET2Cleared 510(K)
- K850175MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S2Cleared 510(K)
- K850176MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-2Cleared 510(K)
- K833782SURGITEK ALL SILICONE INFECTION DOUBJ2Cleared 510(K)
- K834401URETERAL DOUBLE PIGTAIL STENT2Cleared 510(K)
- K840059SILITEK URINARY DIVERSION STENT2Cleared 510(K)
- K832915URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN2Cleared 510(K)
- K831857SURGITEK PERCUTANEOUS ARNEGRADE SILITEK2Cleared 510(K)
- K831446SURGITEK NEPHROSTENT KIT2Cleared 510(K)
- K823487BARD URETERAL STENT2Cleared 510(K)
- K830884SURGITEKS PERCUTANEOUS ANTEGRADE ALL -2Cleared 510(K)
- K820870URETERAL STANT SET2Cleared 510(K)
- K800109SURGITEK URINARY DIVERSION STENT2Cleared 510(K)
- K781641SURGITEK DOUBLE J URETEROL STENT2Cleared 510(K)
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QNEEndoscopic Pancreatic Debridement Device2Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- 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
Malecot Nephrostomy Catheter/Stent Set
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180029
- 510(k) Type
- Traditional
- Applicant
- Cook Incorporated
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/2018
- Days to Decision
- 261 days
- Submission Type
- Summary