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
- 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
- K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)2Cleared 510(K)
- K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)2Cleared 510(K)
- K232596EndoGI S-Path Biliary Stent System2Cleared 510(K)
- K223354EGIS Biliary Single Bare Stent2Cleared 510(K)
- K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible2Cleared 510(K)
- K223469WallFlex™ Biliary RX Stent System2Cleared 510(K)
- K223626Niti-S Biliary Speed D Stent2Cleared 510(K)
- K222663MultiStage Balloon Dilatation Catheter2Cleared 510(K)
- K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers2Cleared 510(K)
- K222627EndoGI S-Path Biliary Stent System2Cleared 510(K)
- K221071Niti-S Biliary Slim M Stent2Cleared 510(K)
- K213946Compass BDS Biliary Stent2Cleared 510(K)
- K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible2Cleared 510(K)
- K210419BIOTEQ Drainage Catheter BT-PDS-series2Cleared 510(K)
- K202973HANAROSTENT Benefit Biliary (NNN)2Cleared 510(K)
- K203162Advanix Biliary Stent with NaviFlex RX Delivery System2Cleared 510(K)
- K200103BIOTEQ Drainage Catheter Set (One Step Type)2Cleared 510(K)
- K202477EndoGI S-Path Biliary Stent System2Cleared 510(K)
- K193600EndoGI Biliary Stent System2Cleared 510(K)
- K181669ConvertX Biliary Stent System2Cleared 510(K)
- K183396HANAROSTENT FASTTM Biliary (NNN)2Cleared 510(K)
- K182980Zilver 518 Biliary Stent, Zilver 635 Biliary Stent2Cleared 510(K)
- K180418Reliant(TM) Multistage Dilatation Balloon Catheter2Cleared 510(K)
- K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set2Cleared 510(K)
- K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets2Cleared 510(K)
- K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set2Cleared 510(K)
- K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter2Cleared 510(K)
- K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S2Cleared 510(K)
- K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter2Cleared 510(K)
- K172520CRE RX Biliary Balloon Dilatation Catheter2Cleared 510(K)
- K171809Epic Biliary Endoscopic Stent System2Cleared 510(K)
- K171623Nasal Pancreatic Drainage Set2Cleared 510(K)
- K171223Quantum TTC Biliary Balloon Dilator2Cleared 510(K)
- K170740GORE VIABIL Short Wire Biliary Endoprosthesis2Cleared 510(K)
- K170743AngioDynamics Total Abscession Biliary Drainage Catheter2Cleared 510(K)
- K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent2Cleared 510(K)
- K162226Reliant Multistage Dilatation Balloon Catheter2Cleared 510(K)
- K163018Zilver 635 Biliary Stent2Cleared 510(K)
- K162404Express SD Biliary Monorail Premounted Stent System2Cleared 510(K)
- K161203Soehendra Stent Retriever2Cleared 510(K)
- K150487X-Suit NIR Biliary Metallic Stent2Cleared 510(K)
- K152853WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary2Cleared 510(K)
- K151925Elation Wireguided Balloon Dilation Catheter2Cleared 510(K)
- K152607Express SD Biliary Monorail Premounted Stent System2Cleared 510(K)
- K151671Disposable Multistage Dilation Balloon Catheter2Cleared 510(K)
- K152524Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set2Cleared 510(K)
- K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter2Cleared 510(K)
- K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter2Cleared 510(K)
- K143303Single Use Biliary Balloon Dilator2Cleared 510(K)
- K141408RESOLVE BILIARY LOCKING DRAINAGE CATHETER2Cleared 510(K)
- K141335EXPEL APD DRAINAGE CATHETER SYSTEM2Cleared 510(K)
- K141597MUSTANG BALLOON DIALATION CATHETER2Cleared 510(K)
- K133110EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K140760BONASTENT BILIARY2Cleared 510(K)
- K140630WALLFLEX BILIARY RX STENT SYSTEM2Cleared 510(K)
- K133700ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS2Cleared 510(K)
- K130981FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET2Cleared 510(K)
- K130792LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM2Cleared 510(K)
- K130484MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER2Cleared 510(K)
- K130591SUPERA VERITAS2Cleared 510(K)
- K121430EVOLUTION BILIARY STENT SYSTEM2Cleared 510(K)
- K122546SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K122072WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE2Cleared 510(K)
- K111627SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K121832RESOLVE BILIARY LOCKING DRAINAGE CATHETER2Cleared 510(K)
- K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K113582ARCHSTENT BILIARY SYSTEM2Cleared 510(K)
- K120452FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K112994CRE DITATATION BALLON2Cleared 510(K)
- K112522FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K111149HANAROSTENT BILIARY (NNN)2Cleared 510(K)
- K112543WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM2Cleared 510(K)
- K112701CHARGER BALLOON DILATATION CATHETER2Cleared 510(K)
- K111766SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS2Cleared 510(K)
- K111315MULTIPURPOSE DRAINAGE CATHETER2Cleared 510(K)
- K110122MUSTANG BALLOON DILATAION CATHETERS2Cleared 510(K)
- K103478SINGLE USE BILIARY DRAINAGE STENT V2Cleared 510(K)
- K103353MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K102519FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX2Cleared 510(K)
- K093893SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K102082EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M0054702Cleared 510(K)
- K101786ADVANIX DOUBLE PIGTAIL BILIARY STENT2Cleared 510(K)
- K101314ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM2Cleared 510(K)
- K101095DIRECT PERORAL CHOLANGIOSCOPY BALLOON2Cleared 510(K)
- K093003BONASTENT BILIARY2Cleared 510(K)
- K092352SCUBA BILIARY STENT SYSTEM2Cleared 510(K)
- K093947ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC2Cleared 510(K)
- K093392MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS2Cleared 510(K)
- K081996FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM2Cleared 510(K)
- K082093BULLSEYE BILIARY STENT SYSTEM2Cleared 510(K)
- K083374WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM2Cleared 510(K)
- K083627WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M005705402Cleared 510(K)
- K090133CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS2Cleared 510(K)
- K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENT2Cleared 510(K)
- K073667NITI-S BILIARY STENT2Cleared 510(K)
- K08173310MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M005708902Cleared 510(K)
- K072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K080037MODIFICATION TO ZILVER 635 BILIARY STENT2Cleared 510(K)
- K081184GORE VIABIL BILILARY ENDOPROSTHESIS2Cleared 510(K)
- K063532BARD E LUMINEXX BILIARY STENT2Cleared 510(K)
- K072720ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM2Cleared 510(K)
- K0723015MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-052Cleared 510(K)
- K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB2Cleared 510(K)
- K071646SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-1202Cleared 510(K)
- K073672SKATER BILIARY CATHETER2Cleared 510(K)
- K063733RESOLVE BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K062264COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM2Cleared 510(K)
- K063481MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM2Cleared 510(K)
- K070610SKATER BILIARY CATHETER2Cleared 510(K)
- K061231WELLFLEX BILIARY RX STENT SYSTEM2Cleared 510(K)
- K061566PRIMUS GPS BILIARY STENT SYSTEM2Cleared 510(K)
- K060557SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS061200602Cleared 510(K)
- K060624MARATHON STENT WITH FUSION TECHNOLOGY2Cleared 510(K)
- K060817OMNILINK. 018 BILIARY STENT SYSTEM2Cleared 510(K)
- K061235LIFESTENT TURBO BILIARY STENT SYSTEM2Cleared 510(K)
- K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX2Cleared 510(K)
- K053459OMNILINK .035 BILIARY STENT SYSTEM2Cleared 510(K)
- K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM2Cleared 510(K)
- K060023ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K060057PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM2Cleared 510(K)
- K053454RX HERCULINK ELITE BILIARY STENT SYSTEM2Cleared 510(K)
- K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEM2Cleared 510(K)
- K053245GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER2Cleared 510(K)
- K052539COOK FORMULA 418 BILIARY STENT SYSTEM2Cleared 510(K)
- K052114BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP2Cleared 510(K)
- K052132MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM2Cleared 510(K)
- K051785FORMULA 418 BILIARY STENT2Cleared 510(K)
- K051124ZILVER 635 BILIARY STENT2Cleared 510(K)
- K050502SINGLE USE BALLOON DILATOR MAXPASSTM2Cleared 510(K)
- K051379PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT2Cleared 510(K)
- K050534XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM2Cleared 510(K)
- K050777PROFORMA HF 4.5 CANNULA, MODEL 050906, 0509072Cleared 510(K)
- K050725PROTEGE GPS SELF-EXPANDING NITINOL STENT2Cleared 510(K)
- K050698MODIFICATION TO:ZILVER 518 BILIARY STENT2Cleared 510(K)
- K050627LIFESTENT TURBO BILIARY STENT SYSTEMS2Cleared 510(K)
- K050501MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM2Cleared 510(K)
- K050103XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM2Cleared 510(K)
- K033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK2Cleared 510(K)
- K043481MODIFICATION TO: ZILVER 635 BILIARY STENT2Cleared 510(K)
- K042985LIFESTENT NT35 BILIARY STENT SYSTEM2Cleared 510(K)
- K043243PRIMUS STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K042969MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K042518ZILVER 518 BILIARY STENT2Cleared 510(K)
- K041962XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 206052Cleared 510(K)
- K042204MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT2Cleared 510(K)
- K041796PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K041423VIABIL BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K041606EXTRACTOR RX RETRIEVAL BALLOON2Cleared 510(K)
- K040930ZILVER BILIARY STENT SYSTEM USW2Cleared 510(K)
- K040800WILOSN-COOK BILIARY DILATION BALLOON2Cleared 510(K)
- K041370LIFESTENT LP SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM2Cleared 510(K)
- K041032MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K040653PARAMOUNT MINI GPS BILIARY STENT SYSTEM2Cleared 510(K)
- K040667XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S60082Cleared 510(K)
- K040027BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K040550LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K040505ZILVER 635 BILIARY STENT2Cleared 510(K)
- K040151OASIS BILIARY STENT INTRODUCTION SYSTEM2Cleared 510(K)
- K033909WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM2Cleared 510(K)
- K033497BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K032436DURAMAX .018 BILIARY STENT SYSTEM2Cleared 510(K)
- K033834OMNILINK .018 BILIARY STENT SYSTEM2Cleared 510(K)
- K033394CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM2Cleared 510(K)
- K033348ZILVER 518 BILIARY STENT2Cleared 510(K)
- K033537SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S30052Cleared 510(K)
- K033314PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K033134MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K011261STONE EXTRACTOR BALLOON CATHETER2Cleared 510(K)
- K033333SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B2Cleared 510(K)
- K033393ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM2Cleared 510(K)
- K033212LIFESTENT SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K032530MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM2Cleared 510(K)
- K032929MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 148222Cleared 510(K)
- K032580PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K032768MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)2Cleared 510(K)
- K032025SENTINOL NITINOL BILLARY STENT SYSTEM2Cleared 510(K)
- K031360GI SUPPLY BILIARY STENT2Cleared 510(K)
- K032137PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K032457MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K030633MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT2Cleared 510(K)
- K032360MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT2Cleared 510(K)
- K031331WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K032206PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION2Cleared 510(K)
- K031821MODIFICATION TO COOK ZILVER BILIARY STENT2Cleared 510(K)
- K030638DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML2Cleared 510(K)
- K031777MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K024303EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K031197MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K030839MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)2Cleared 510(K)
- K031186LUMINEXX ENDOSCOPIC BILIARY STENT2Cleared 510(K)
- K021672PANCREATIC DRAINAGE TUBE2Cleared 510(K)
- K023308LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K030053JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX68102Cleared 510(K)
- K030645BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT2Cleared 510(K)
- K030107100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM2Cleared 510(K)
- K030409SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM2Cleared 510(K)
- K023121LIFESTENT BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K023248LIFESTENT LP SDS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 14108302Cleared 510(K)
- K024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K021994BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K023870FLEXIMA BILIARY CATHETER2Cleared 510(K)
- K014215VIABIL BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K023243MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K023217MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K021630BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K021898SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K022026MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)2Cleared 510(K)
- K021824DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 1010102Cleared 510(K)
- K021345MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM2Cleared 510(K)
- K021729MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K020788WILSON-COOK ZILVER BILIARY STENT2Cleared 510(K)
- K020528INTRASTENT LD (LARGE DIAMETER) STENT2Cleared 510(K)
- K020809MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT2Cleared 510(K)
- K020682BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON2Cleared 510(K)
- K020052SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K014184MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)2Cleared 510(K)
- K014136MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K014205MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)2Cleared 510(K)
- K014007DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K011909ULTRA-THIN SDS BALLOON DILATATION CATHETER2Cleared 510(K)
- K010601FANELLI BILIARY STENT2Cleared 510(K)
- K012752WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE2Cleared 510(K)
- K012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX2Cleared 510(K)
- K011080BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM2Cleared 510(K)
- K012993MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K012590CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM2Cleared 510(K)
- K011806PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K010411PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K012347PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K011817BRIDGE FX2Cleared 510(K)
- K012216NIROYAL BILIARY PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K011184INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K010242COOK ZILVER BILIARY STENT2Cleared 510(K)
- K012090CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT2Cleared 510(K)
- K012087CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT2Cleared 510(K)
- K012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM2Cleared 510(K)
- K012066PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K010107R STENT BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K011881DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K011506OMNILINK .035 BILIARY STENT SYSTEM2Cleared 510(K)
- K011039OMNILINK .018 BILIARY STENT SYSTEM2Cleared 510(K)
- K010684RX HERCULINK PLUS BILIARY STENT SYSTEM2Cleared 510(K)
- K003929NIROYAL BILIARY PREMOUNTED STENT SYSTEM2Cleared 510(K)
- K010445PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM2Cleared 510(K)
- K002650VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-7262Cleared 510(K)
- K003997INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K002235HORIZONS ERCP CANNULA2Cleared 510(K)
- K003186BARD MEMOTHERM ENDOSCOPIC BILIARY STENT2Cleared 510(K)
- K003793BARD LUMINEXX BILIARY STENT2Cleared 510(K)
- K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE2Cleared 510(K)
- K003040INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY2Cleared 510(K)
- K003450INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K003365S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)2Cleared 510(K)
- K003336MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K002130NIR BILIARY STENT2Cleared 510(K)
- K002143DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K002133NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER2Cleared 510(K)
- K001338MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER2Cleared 510(K)
- K001648INTRASTENT DOUBLESTRUT PARAMOUNT2Cleared 510(K)
- K002101ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K001843S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K001258BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K000744MEDTRONIC AVE BRIDGE X3 STENT2Cleared 510(K)
- K000308WALLSTENT BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K001224RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 1002Cleared 510(K)
- K001222OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 12Cleared 510(K)
- K000864INTRASTENT DOUBLESTRUT XS STENT2Cleared 510(K)
- K0007931 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K000564CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY2Cleared 510(K)
- K993303SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER2Cleared 510(K)
- K000550OTW MEGALINK SDS BILIARY STENT SYSTEM2Cleared 510(K)
- K993904INTRASTENT DOUBLESTRUT LD2Cleared 510(K)
- K994156MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B2Cleared 510(K)
- K993892DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-452Cleared 510(K)
- K993392BARD MEMOTHERM FLEXX BILIARY STENT2Cleared 510(K)
- K993232WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM2Cleared 510(K)
- K994068S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K990808PBN DILATORS2Cleared 510(K)
- K993588MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,2Cleared 510(K)
- K993091PALMAZ XL TANSHEPATIC BILIARY STENTS2Cleared 510(K)
- K993145MEDTRONIC AVE BRIDGE STENT2Cleared 510(K)
- K992816MODIFICATION TO INTRASTENT2Cleared 510(K)
- K992319RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM2Cleared 510(K)
- K992755CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE2Cleared 510(K)
- K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-182Cleared 510(K)
- K990592INTRASTENT II2Cleared 510(K)
- K992569MEDTRONIC AVE BRIDGE STENT2Cleared 510(K)
- K991674CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS2Cleared 510(K)
- K991929INTRASTENT2Cleared 510(K)
- K991028CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES2Cleared 510(K)
- K992318MEDTRONIC AVE BRIDGE STENT2Cleared 510(K)
- K990854INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE2Cleared 510(K)
- K991533MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION2Cleared 510(K)
- K991793ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM2Cleared 510(K)
- K983154CYSTIC DUCT BALLOON DILATING CATHETER2Cleared 510(K)
- K991032GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-582Cleared 510(K)
- K990631CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC2Cleared 510(K)
- K983075GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-382Cleared 510(K)
- K990130WILSON-COOK PANCREATIC WEDGE STENT2Cleared 510(K)
- K982346ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM2Cleared 510(K)
- K980823CORDIS NITINOL STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K983008PERIPHERAL AVE STENT SYSTEM2Cleared 510(K)
- K973171NIR BILIARY STENT2Cleared 510(K)
- K982508FLEXIMA2Cleared 510(K)
- K982005WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K980290ITI STENT2Cleared 510(K)
- K980653PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM2Cleared 510(K)
- K980372MANAN VS ACCESS NEEDLE/SET2Cleared 510(K)
- K980191MANAN BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K974815MANAN(TM) INTRODUCER SHEATH/NEEDLE2Cleared 510(K)
- K973008COURIER ST BALLOON DILATATION CATHETER2Cleared 510(K)
- K972582URESIL GUIDEWIRE2Cleared 510(K)
- K973113MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM2Cleared 510(K)
- K971295AVE BRIDGE STENT SYSTEM2Cleared 510(K)
- K972825OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB2Cleared 510(K)
- K973114SILICONE BILIARY STENT/BILIARY CATHETER2Cleared 510(K)
- K972583URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S2Cleared 510(K)
- K965147BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K964688LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT2Cleared 510(K)
- K963254SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM2Cleared 510(K)
- K962899ULTRAFLEX DIAMOND2Cleared 510(K)
- K963767MANAN V.S. ACCESS NEEDLE/SET2Cleared 510(K)
- K963782BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K964119WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K970052EXTRACTORRX2Cleared 510(K)
- K963691COURIER BALLOON DILATATION CATHETER2Cleared 510(K)
- K963397ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER2Cleared 510(K)
- K955110NAVARRE PERCUTANEOUS BILIARY DRAINAGE2Cleared 510(K)
- K962925OLYMPUS B-5/B-7 SERIESBALLOON CATHETER2Cleared 510(K)
- K954713DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)2Cleared 510(K)
- K961216MANAN INTRODUCER SHEALTH/NEEDLE2Cleared 510(K)
- K961262WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K955126LMI BILIARY CATHETER2Cleared 510(K)
- K955728CORDIS BILIARY STENT2Cleared 510(K)
- K954043MANAN BILIARY DRAINAGE CATHETER2Cleared 510(K)
- K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER2Cleared 510(K)
- K953332MS CLASSIQUE BALLOON DILATATION CAHTETER2Cleared 510(K)
- K945498INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K924387INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS2Cleared 510(K)
- K953827GIP/MEDI-GLOBE ERCP CATHETERS2Cleared 510(K)
- K941973GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES2Cleared 510(K)
- K944912OLYMPUS NBD TUBES2Cleared 510(K)
- K933200OLYMPUS PBD STENTS2Cleared 510(K)
- K944143MS CLASSIQUE BALLOON CATHETER2Cleared 510(K)
- K941350WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER2Cleared 510(K)
- K943143BILIARY STENT2Cleared 510(K)
- K935094BALLOON DILATION CATHETER2Cleared 510(K)
- K925406BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM2Cleared 510(K)
- K923993WALLSTENT BILIARY ENDOPROTHESES2Cleared 510(K)
- K930623MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH2Cleared 510(K)
- K940370AMERICAN CATHETER E.R.C.P. CANNULA2Cleared 510(K)
- K940965ELIMINATOR BALLOON DILATOR2Cleared 510(K)
- K934377INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.2Cleared 510(K)
- K924608HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS2Cleared 510(K)
- K931025INTHERM STASIS VALVE SYSTEM2Cleared 510(K)
- K923096URESIL BILLIARY CATHETER2Cleared 510(K)
- K924107ERCP CANNULA2Cleared 510(K)
- K920361BARD BILIARY BALLOON DILATORS2Cleared 510(K)
- K924451INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR2Cleared 510(K)
- K921654MCLEAN-STOCK PERCUTANEOUS T-TUBE SET2Cleared 510(K)
- K921191GIANTURCO-ROSCH BILIARY Z STENT2Cleared 510(K)
- K920236CHOLANGIOGRAM CATHETER KIT2Cleared 510(K)
- K915813ACKRAD ERCP CONTRAST DELIVERY SET2Cleared 510(K)
- K914699URESIL FIXATION DEVICE2Cleared 510(K)
- K914495E.R.C.P. CATHETER2Cleared 510(K)
- K913986CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM2Cleared 510(K)
- K914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K914277WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY2Cleared 510(K)
- K913932PERCUTANEOUS DILATOR WITH SHEATH2Cleared 510(K)
- K913073DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT2Cleared 510(K)
- K9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH2Cleared 510(K)
- K911630LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON2Cleared 510(K)
- K912288WILTEK STANDARD CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K912122CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K912971INTHERM RADIALLY EXPANDING DILATER2Cleared 510(K)
- K900205DRAINAGE CATHETERS W/A DISSOLVABLE TIP2Cleared 510(K)
- K911581PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION2Cleared 510(K)
- K910671MODEL GS-4700 COMMON DUCT STONE REMOVING KIT2Cleared 510(K)
- K911292SCHNEIDER WALLSTENT(R)2Cleared 510(K)
- K910219LAPAROMED CHOLANGIOGRAM DEVICE2Cleared 510(K)
- K910931BILIARY BALLOON DILATATION CATHETER2Cleared 510(K)
- K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K905738OPERATIVE CHOLANGIOGRAPHIC CATHETER2Cleared 510(K)
- K910768SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE2Cleared 510(K)
- K904669BALLOON CATHETERS2Cleared 510(K)
- K910006AVD INTIMAX (TM) BILIARY CATHETER2Cleared 510(K)
- K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS2Cleared 510(K)
- K905714ERCP CANNULA2Cleared 510(K)
- K905229LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS2Cleared 510(K)
- K900923ZIMMON ENDOSCOPIC PANCREATIC STENT2Cleared 510(K)
- K903420SOEHENDRA STENT RETRIEVER2Cleared 510(K)
- K903858COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION2Cleared 510(K)
- K902734PR CANNULAS2Cleared 510(K)
- K902107WILSON-COOK SYRINGE HOLDERS2Cleared 510(K)
- K901582DOBBHOFF BILIARY STENT SET2Cleared 510(K)
- K901427BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON2Cleared 510(K)
- K901433SURE-FLEX ANASTOMOTIC BALLOON DILATOR2Cleared 510(K)
- K901432BILIARY BALLOON DILATOR2Cleared 510(K)
- K901431TELEMED ERCP CANNULA2Cleared 510(K)
- K900904CANDELA DIRECTABLE BILIARY CATHETER SYSTEM2Cleared 510(K)
- K896323WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS2Cleared 510(K)
- K896391BARD/ANGIOMED STENTS2Cleared 510(K)
- K896518DOBBHOFF(R) ERCP CANNULA2Cleared 510(K)
- K896503PORGES ERCP CATHETERS2Cleared 510(K)
- K896506PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR2Cleared 510(K)
- K896504PORGES 2-WAY BALLOON EXTRACTION CATHETER2Cleared 510(K)
- K896423PORGES BILIARY STENTS2Cleared 510(K)
- K896376PORGES NASOBILIARY DRAIN2Cleared 510(K)
- K894867WILTEK E.R.C.P. CATHETER2Cleared 510(K)
- K894871WILTEK BILIARY STENT SET2Cleared 510(K)
- K896069WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT2Cleared 510(K)
- K896163SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.2Cleared 510(K)
- K884714BILIARY DIALATOR2Cleared 510(K)
- K892384BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER2Cleared 510(K)
- K892383BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET2Cleared 510(K)
- K880343BURNEY GALLBLADDER CATHETER KIT2Cleared 510(K)
- K882610COOK-GIANTURCO BILIARY Z STENT2Cleared 510(K)
- K885180EXPANDABLE BILIARY STENT ENDOPROSTHESIS2Cleared 510(K)
- K873606MODIFIED COPE SUTURE ANCHOR2Cleared 510(K)
- K873954NAMIC HAWKINS UNIVERSAL DRAINAGE SET2Cleared 510(K)
- K872509LINDEN STONE EXTRACTION BALLOON2Cleared 510(K)
- K872458AN3200 DOUBILET DRAIN2Cleared 510(K)
- K861291GASTROTOPO2Cleared 510(K)
- K863571BILIARY BALLOON CATHETER2Cleared 510(K)
- K862059SHEATH, ENDOSCOPE2Cleared 510(K)
- K863437BARD BALLOON DILATATION SYSTEM2Cleared 510(K)
- K863957TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU2Cleared 510(K)
- K861220LUNDERQUIST - RING PTC DRAINAGE CATHETER2Cleared 510(K)
- K860990ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY2Cleared 510(K)
- K855142ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY2Cleared 510(K)
- K851954PVL-4.8-200 BALLOON STONE EXTRACTOR2Cleared 510(K)
- K851962ZIMMON BILIARY STENT SET2Cleared 510(K)
- K853666ENDODYNAMICS SIEGEL THERAPUTIC STENT2Cleared 510(K)
- K852293BARD-PARKER BILIARY BALLOON CATHETER2Cleared 510(K)
- K853543DAVOL RETRIEVAL BALLOON CATHETER2Cleared 510(K)
- K851242GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO2Cleared 510(K)
- K851960SOEHENDRA BILIARY DILATING CATHETER-SBDC-72Cleared 510(K)
- K851647OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO2Cleared 510(K)
- K851956VPDS-1 VENNES PANCREATIC DILATION SET2Cleared 510(K)
- K844384BILIARY STENT PROSTHESIS2Cleared 510(K)
- K842147CATH-TECH CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K834413DILATION BALLOON CATHETER2Cleared 510(K)
- K834468DRAINAGE STENT2Cleared 510(K)
- K834574USCI ENDOPROSTHESIS2Cleared 510(K)
- K834351BILIARY INDWELLING STENT2Cleared 510(K)
- K833937UMI PERCUTANEOUS TRANSHEPATIC CHOLAN2Cleared 510(K)
- K833920KELLY CHOLANGIOCATH2Cleared 510(K)
- K830483COONS SOFT STENT2Cleared 510(K)
- K823428KELLY INFLATABLE T DRAIN2Cleared 510(K)
- K821819PIGTAIL STENTS2Cleared 510(K)
- K821817PIGTAIL NASAL CATHETERS2Cleared 510(K)
- 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
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product 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
- 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
Compass BDS Biliary Stent
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213946
- 510(k) Type
- Traditional
- Applicant
- Cook Ireland LTD
- Country
- Ireland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/9/2022
- Days to Decision
- 143 days
- Submission Type
- Summary