Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Cook Incorporated

FDA 510(k) & PMA Approved Devices — 147 products

Total Devices147
Categories53
Latest Approval2024-03-08
TypeNumberDevice NameCodeDate
510(k) K233177 Nest VT Vitrification Device MQK 2024-03-08 View
510(k) K222254 Gunther Tulip Vena Cava Filter Retrieval Set MMX 2023-05-16 View
510(k) K223098 Bakri Essential Postpartum Balloon OQY 2022-10-28 View
510(k) K210734 Endovascular Dilator and Sets DRE 2021-04-06 View
510(k) K203670 Extra Large Check-Flo Introducer DYB 2021-02-16 View
510(k) K191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc LJE 2020-01-29 View
510(k) K190903 Lawson Retrograde Nephrostomy Wire Puncture Set LJE 2019-12-16 View
510(k) K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set JOH 2019-12-12 View
510(k) K191163 Lumax Guiding Catheter DQY 2019-12-12 View
510(k) K190084 McLean-Ring Enteral Feeding Tube Set KNT 2019-10-11 View
510(k) K183323 UPJ Occlusion Balloon Catheter EYB 2019-08-05 View
510(k) K182985 Roadrunner PC Wire Guide, Olcott Torque Device DQX 2019-07-22 View
510(k) K183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set LJE 2019-07-16 View
510(k) K182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set KGC 2019-06-26 View
510(k) K191485 Deflectable Brush Biopsy Set FDX 2019-06-26 View
510(k) K182695 Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter EYB 2019-06-17 View
510(k) K182403 Peel-Away Introducer FED 2019-05-29 View
510(k) K183035 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle LJE 2019-05-17 View
510(k) K191015 Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) MQF 2019-05-17 View
510(k) K182252 Cook Unimpregnated Central Venous Catheter FOZ 2019-05-17 View
510(k) K182231 Brush Biopsy Set ; Deflectable Brush Biopsy Set FDX 2019-05-01 View
510(k) K182071 Multi-Sideport Catheter Infusion Set KRA 2019-04-25 View
510(k) K181971 Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set FAD 2019-04-23 View
510(k) K182399 Park Blade Septostomy Catheter DXF 2019-04-04 View
510(k) K181770 Intrauterine Access Balloon Catheter, Selective Salpingography Catheter LKF 2019-03-29 View
510(k) K181735 Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set LJE 2019-03-27 View
510(k) K181722 Polyethylene Catheter DQO 2019-03-22 View
510(k) K181353 Lunderquist® Fixed Core Wire Guide DQX 2019-02-15 View
510(k) K181097 Cook Cystostomy Catheter Set KOB 2019-01-18 View
510(k) K183467 Roadrunner Extra Support Wire Guide DQX 2019-01-11 View
510(k) K182709 One-Step Suprapubic Introducer KOB 2018-12-26 View
510(k) K183036 Dilator Sets DRE 2018-12-20 View
510(k) K180830 Reuter Tip Deflecting Wire Guide DQX 2018-12-20 View
510(k) K180846 Arterial Pressure Monitoring Set/Tray DQO 2018-12-19 View
510(k) DEN170055 Retrograde Intubation Set QCX 2018-12-12 View
510(k) K180792 Arterial Pressure Monitoring Set/Tray DQO 2018-11-30 View
510(k) K180557 Greene Renal Transplant Stent Set FAD 2018-11-23 View
510(k) K181757 Günther Tulip® Vena Cava Filter Retrieval Set MMX 2018-11-06 View
510(k) K182066 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set KOB 2018-10-30 View
510(k) K180291 Cook Silicone Balloon HSG Catheter LKF 2018-10-26 View
510(k) K180286 Polyethylene Catheter DQO 2018-10-26 View
510(k) K180300 Margolin HSG Cannula, Goldstein Sonohysterography Catheter LKF 2018-10-26 View
510(k) K180302 Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter MQF 2018-10-24 View
510(k) K180054 Royal Flush Plus High-Flow Catheter DQO 2018-10-05 View
510(k) K180216 Seidmon Antegrade AQ Stent Set FAD 2018-09-28 View
510(k) K180029 Malecot Nephrostomy Catheter/Stent Set FAD 2018-09-21 View
510(k) K180182 Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter EYB 2018-09-14 View
510(k) K180053 Sof-Flex Ureteral Stent Set FAD 2018-09-13 View
510(k) K173657 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter EZL 2018-08-23 View
510(k) K181713 Ultraxx Nephrostomy Balloon Catheter Set LJE 2018-08-17 View
510(k) K181431 Laser Ureteral Catheter GEX 2018-07-30 View
510(k) K181712 San Antonio Stopcock ODC 2018-07-26 View
510(k) K171272 Cook-Swartz Doppler Flow Probe ITX 2018-07-17 View
510(k) K173654 Ureteral Dilator Sets, Ureteral Dilators EZN 2018-07-17 View
510(k) K180552 Modified Novy Cornual Cannulation Set MOV 2018-07-12 View
510(k) K181144 Angled Tip Ureteral Catheter KOD 2018-06-28 View
510(k) K173414 Advance Biliary Balloon Catheter GCA 2018-06-22 View
510(k) K181351 Double Flexible Tipped Wire Guides DQX 2018-06-14 View
510(k) K173155 Pakter Curved Needle Set BSP 2018-06-07 View
510(k) K171609 Check-Flo Performer Introducer Micropuncture Radial Artery Access Set DYB 2018-06-04 View
510(k) K180756 Safety Wire Guide Introducer EZN 2018-05-24 View
510(k) K180034 Weinmann Tracheostomy Exchange Set JOH 2018-05-07 View
510(k) K172980 Micropuncture Pedal Access Set DYB 2018-05-03 View
510(k) K180028 Cook 810 Set, Desilets-Hoffman Introducer Set EZN 2018-05-02 View
510(k) K173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets FGE 2018-05-01 View
510(k) K171917 Frova Intubating Introducer BTR 2018-04-23 View
510(k) K172588 Balloon Catheter and Balloon Ureteral Dilator Set EZN 2018-04-19 View
510(k) K171603 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set FAD 2018-04-16 View
510(k) K173103 Pivet and Soft-Pass Embryo Transfer Catheter Sets MQF 2018-04-13 View
510(k) K173686 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter MQF 2018-04-11 View
510(k) K172635 High-Flo Silver Polyethylene Catheter DQO 2018-04-03 View
510(k) K171988 Performer Guiding Sheath DYB 2018-03-30 View
510(k) K171997 Mandril Wire Guide DQX 2018-03-30 View
510(k) K172017 Black Silicone Filiform Double Pigtail Stent Set FAD 2018-03-26 View
510(k) K173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter ODC 2018-03-22 View
510(k) K171912 Double Flexible Tip Wire Guides DQX 2018-03-19 View
510(k) K171764 Fixed Core Wire Guides DQX 2018-03-09 View
510(k) K171820 Transjugular Liver Access Sets DYB 2018-03-09 View
510(k) K171810 Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter KOD 2018-03-07 View
510(k) K171915 Nathanson Transcystic Bile Duct Stone Exploration Pack LQR 2018-03-01 View
510(k) K171601 Ultraxx Nephrostomy Balloon Catheter LJE 2018-02-23 View
510(k) K171994 Silicone Peripherally Inserted Central Venous Catheter Set/Tray LJS 2018-02-22 View
510(k) K171600 Renal Access Cobra Catheter, Kumpe Access Catheter KOD 2018-02-16 View
510(k) K171604 Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip LKF 2018-02-15 View
510(k) K171662 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter KOD 2018-02-01 View
510(k) K171264 Royal Flush Catheter DQO 2018-01-25 View
510(k) K172051 Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter MQF 2018-01-10 View
510(k) K171445 Amplatz Support Wire Guide with Apex Curve DQX 2018-01-10 View
510(k) K171948 Roadrunner Extra Support Wire Guide DQX 2018-01-05 View
510(k) K172321 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters MQF 2017-12-21 View
510(k) K171275 Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design DYB 2017-12-20 View
510(k) K173685 Peel-Away Introducer Set DYB 2017-12-20 View
510(k) K173687 Strange Bile Duct Stone Exploration Set LQR 2017-12-15 View
510(k) K172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath FED 2017-12-13 View
510(k) K170898 Wittich Nitinol Stone Basket LQR 2017-12-12 View
510(k) K172278 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent GBM 2017-11-22 View
510(k) K173355 Gastric Sizing Balloon Catheter KNT 2017-11-17 View
510(k) K173068 Performer Introducer DYB 2017-11-17 View
510(k) K173289 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter DQO 2017-11-15 View
510(k) K170931 CXI TriForce Peripheral Crossing Set KRA 2017-11-13 View
510(k) K173009 NCompass Nitinol Stone Extractors LQR 2017-11-07 View
510(k) K172325 Rhapsody H-30 Holmium Laser System GEX 2017-10-26 View
510(k) K172527 Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe LJE 2017-10-19 View
510(k) K170298 Liberator Beacon Tip Locking Stylet DRB 2017-10-18 View
510(k) K170020 Peel-Away Introducer Set DYB 2017-09-28 View
510(k) K170323 Entuit Start Initial Placement Gastrostomy Set KGC 2017-09-14 View
510(k) K170010 Salle Intraoperative Pyeloplasty Stent Set FAD 2017-08-28 View
510(k) K171853 Liver Access and Biopsy Sets DYB 2017-08-24 View
510(k) K171897 Approach CTO Microwire Guide DQX 2017-08-21 View
510(k) K162729 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip BSR 2017-08-11 View
510(k) K171999 Performer Introducer DYB 2017-07-31 View
510(k) K171602 Williams Cystoscopic Injection Needle FBK 2017-07-28 View
510(k) K163031 Bunegin-Albin Air Aspiration Set DXE 2017-07-27 View
510(k) K163318 Soules Intrauterine Insemination Catheter MQF 2017-07-14 View
510(k) K163353 Needle's Eye Snare Retrieval Set - 54cm DXE 2017-07-11 View
510(k) K162109 Kwart Retro-Inject Ureteral Stent FAD 2017-06-07 View
510(k) K162448 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter DQO 2017-05-26 View
510(k) K170603 Tao Brush I.U.M.C. Endometrial Sampler HFE 2017-05-24 View
510(k) K163197 Cook Holmium Laser Fiber GEX 2017-05-24 View
510(k) K160567 Barone Jejunostomy Catheter Set KNT 2017-05-18 View
510(k) K160509 Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube KNT 2017-05-18 View
510(k) K170616 van Andel Dilatation Catheter DRE 2017-04-28 View
510(k) K162104 C-Flex Ureteral Stent Set FAD 2017-04-24 View
510(k) K170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component OQY 2017-03-31 View
510(k) K170008 Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set KNW 2017-02-28 View
510(k) K160200 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set BWC 2017-02-17 View
510(k) K170193 Advance 14LP Low Profile PTA Balloon Dilatation Catheter LIT 2017-02-13 View
510(k) K161236 Universa Firm Ureteral Stents and Stent Sets FAD 2017-01-27 View
510(k) K161504 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray MPB 2017-01-06 View
510(k) K160884 CXI Support Catheter KRA 2016-11-22 View
510(k) K161822 Torcon NB Advantage Catheters DQO 2016-10-27 View
510(k) K161496 Turbo-Flo PICC Sets LJS 2016-10-07 View
510(k) K160217 uVue HSG/SHG Catheter LKF 2016-10-06 View
510(k) K161002 Aprima Smartesis Centesis Pump BTA 2016-09-28 View
510(k) K153761 Emergency Transtracheal Airway Catheter BWC 2016-09-22 View
510(k) K160593 Indy OTW Vascular Retriever MMX 2016-09-02 View
510(k) K160219 Hilal Embolization MicroCoils KRD 2016-08-03 View
510(k) K160542 5.0 Fr Arndt Endobronchial Blocker Set CBI 2016-08-02 View
510(k) K161801 CrossCath Support Catheter KRA 2016-07-29 View
510(k) K160887 Cook Intraosseous Infusion Needles FMI 2016-07-26 View
510(k) K161218 Gianturco-Roehm Bird’s Nest Vena Cava Filter DTK 2016-07-22 View
510(k) K160891 Ultrathane Endoureterotomy Stent Set FAD 2016-06-24 View
510(k) K153778 Nester Embolization Coils, Tornado Embolization Coils KRD 2016-05-19 View
510(k) K160223 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter NHC 2016-04-08 View
510(k) K153430 Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select DYB 2016-03-07 View
510(k) K151051 Universa Soft Ureteral Stents and Stent Sets FAD 2016-01-11 View
510(k) K151018 Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette MQH 2016-01-08 View
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