FDA Registration Active 🇺🇸 United States

COOK MEDICAL LLC

Reg #: 3005580113 · FEI: 3005580113 · Expires 2026
Products
65
Proprietary Names
201
Establishment Types
2
Classifications
65

Registration Details

Registration Name
COOK MEDICAL LLC
Registration Number
3005580113
FEI Number
3005580113
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
400 DANIELS WAY
City
Bloomington
State
IN
ZIP
47404
Country
US

Regulatory Submissions

510(k) Number
K022002
PMA Number
P020018

Owner / Operator

Firm Name
COOK MEDICAL
Operator Number
9090900
Address
400 DANIELS WAY, --
City
Bloomington
State
IN
Postal Code
47404
Country
US
Correspondent
Ed - Sutkowski

Products

Device Name Product Code
Wire, Guide, Catheter DQX
Media, Reproductive MQL
Instrument, Biopsy KNW
Electrode, Electrosurgical, Active, Urological FAS
Introducer, Catheter DYB
Tubes, Gastrointestinal (And Accessories) KNT
Syringe, Balloon Inflation MAV
Dilator, Urethral KOE
Catheter, Assisted Reproduction MQF
Endoscopic Irrigation/Suction System OCX
Filter, Intravascular, Cardiovascular DTK
Powered Laser Surgical Instrument GEX
Endoscopic Transhepatic Venous Access Needle QIJ
Stents, Drains And Dilators For The Biliary Ducts FGE
Endoscopic Access Overtube, Gastroenterology-Urology FED
Catheter, Nephrostomy, General & Plastic Surgery GBO
Catheter, Nephrostomy LJE
Biopsy Needle FCG
Endoscopic Ultrasound System, Gastroenterology-Urology ODG
Catheter, Angioplasty, Peripheral, Transluminal LIT
Accessory, Assisted Reproduction MQG
System, Endovascular Graft, Aortic Aneurysm Treatment MIH
Needle, Assisted Reproduction MQE
Catheter And Tip, Suction JOL
Snare, Non-Electrical FGX
Stent, Iliac Vein QAN
Prosthesis, Esophageal ESW
Cleaner, Ultrasonic, Medical Instrument FLG
Cystoscope And Accessories, Flexible/Rigid FAJ
Forceps, Biopsy, Non-Electric FCL
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Stent, Ureteral FAD
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Transducer, Blood-Pressure, Extravascular DRS
Ureteroscope And Accessories, Flexible/Rigid FGB
Stent, Metallic, Expandable, Duodenal MUM
Stent, Colonic, Metallic, Expandable MQR
Iliac Covered Stent, Arterial PRL
Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Tape And Bandage, Adhesive KGX
Stent, Iliac NIO
Stent, Superficial Femoral Artery NIP
Dilator, Vessel, For Percutaneous Catheterization DRE
Stent, Superficial Femoral Artery, Drug-Eluting NIU
Ligator, Hemorrhoidal FHN
Anoscope And Accessories FER
Endoscopic Bite Block MNK
Needle, Aspiration And Injection, Disposable GAA
Accessories, Catheter KGZ
Accessories, Cleaning Brushes, For Endoscope MNL
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Tube, Aspirating, Flexible, Connecting BYY
Gastrointestinal Tubes With Enteral Specific Connectors PIF
Tube, Tracheal (W/Wo Connector) BTR
Device, Vascular, For Promoting Embolization KRD
Catheter For Crossing Total Occlusions PDU
Retractor GAD
Endoscope Channel Accessory ODC
Stent, Renal NIN
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
Blood Detection Capsule QUD
Catheter, Percutaneous DQY
Lubricant, Patient KMJ
Endoscope Introducer Kit NWU

Proprietary Names

Fixed-Core Wire Guides Sydney IVF Culture Oil Semi-Automatic Needle Automatic Biopsy Needle BAM Automatic Biopsy Needle Semi-Automatic Needle BIM Omnitech Electrodes Peel-Away Sheath Introducer QL Inflation Device Transmyometrial Embryo Transfer Set Sentrus Insufflation Tubing Sentrus Hybrid Irrigation Tubing Sentrus Irrigation Tubing Sentrus Insufflation Tubing with CO2 Connector Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Cook Celect Platinum Vena Cava Filter set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Quanta System Surgical Laser Fibers EchoTip Ingight Portosystemic Pressure Gradient Measurement System Entuit Thrive Balloon Retention Gastrostomy Feeding Tube Sydney IVF PVP Zilver 635 Biliary Self Expanding Metal Stent Syfonix Suction Ureteral Access Sheath Disposable Ureteral Access Sheath Peel-Away Introducer Set Peel-Away Introducer Sheath Set Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath Flexor® Ureteral Access Sheath Pigtail Drainage Catheter Needle Set Percutaneous Nephrostomy Set Nephrostomy Pigtail Drainage Catheter Multipurpose Drainage Catheters and Sets EchoTip® ClearCore™ EUS Biopsy Needle EchoTip AcuCore™ EUS Biopsy Needle Advance Serenity 18 Hydrophilic PTA Balloon Catheter Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter Stent Introducer Set Solus(R) Double Pigtail Stent with Introducer Oasis-One Action Stent Introduction system(R) ST-2 Soehendra® Tannenbaum® Biliary Stent Cotton-Leung Biliary Stent Set Fusion Oasis One Action Stent Introduction System Pushing Catheter Guiding Catheter Oasis-one action stent introduction system® with Pre-loaded Cotton-Leung® Biliary Stent Cotton-Huibregtse(R) Biliary Stent Cotton-Leung® (Amsterdam) Biliary Stent Set Cotton-Huibregtse® Biliary Stent Set Fusion® Pushing Catheter Cotton-Leung® Biliary Stent Fusion® Oasis® – One Action Stent Introducer System Solus Biliary Stent and Introducer Set Cotton Leung Oasis® Stent Introduction System Zimmon(R) Biliary stent Huibregtse Guiding Catheter Zimmon® Biliary Stent Set Oasis® One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum® Biliary Stent COOK Ultra Quiet Vacuum Pump & Regulator Sydney IVF Sperm Solutions MPIS Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) Ovum Pick-up Aspiration Needle Wayne Pneumothorax Catheter Set and Tray Disposable Polypectomy Cold Snare Zilver® VenaTM Venous Self-Expanding Stent Lunderquist® Extra Stiff Wire Guide DC Wire Guides Adv Serenity 014 COOK Mini-Incubator Evolution® Esophageal Stent System-Partially Covered Sentrus Endoscopic Bedside Kit Sentrus Cleaning Sponge Sydney IVF Sperm Cryopreservation Buffer Flexor Guiding Sheath Flexor Introducer Ascend™ Single-Use Flexible Cysto-Nephroscope HD, Standard Ascend™ Single-Use Flexible Cysto-Nephroscope HD, Reverse Ascend™ Single-Use Flexible Cysto-Nephroscope Esophageal TTS Stent Evolution® Esophageal Stent System- Fully Covered Evolution® Esophageal Controlled-Release Stent -Fully Covered Mandril Wire Guide BIGopsy ng forceps BIGopsy® Backloading Biopsy Forceps EndoTNeedle Resonance® Stent Introducer Resonance Stent Set Resonance Positioner Resonance® Metallic Ureteral Stent and Introducer Compass Cast and MAP Ascend™ Single-Use Flexible Ureteroscope, Standard Endoscopic Video Image Processor HD Ascend™ Single-Use Flexible Ureteroscope, Reverse Niti-S Biliary Stent Evolution® Duodenal Controlled-Release Stent - Uncovered Evolution® Duodenal Stent System- Uncovered iCast covered stent system Volante Steerable Guiding Sheath Ascend Single-Use Flexible Ureteroscope Sydney IVF Hyaluronidase (bovine only - not ovine) Colon Decompression Set ECHOTIP® ULTRA Celiac Plexus Neurolysis Needle Nasal Pancreatic Drainage Set EchoTip® Ultra High Definition Ultrasound Access Needle Geenen® Pancreatic Stent Set Geenen Sofflex Pancreatic Stent Zimmon® Pancreatic Stent Set Geenen® Pancreatic Stent Zimmon® Pancreatic Stent Johlin Pancreatic Wedge Stent Nasal Biliary Drainage Catheter Liguory Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Set Radiopaque Tip Leung Nasal Biliary Drainage Catheter Nagaraja Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Catheter Leung Nasal Biliary Drainage Set Nasal Biliary Drainage Set Nagaraja Nasal Biliary Drainage Catheter Flexgrip Zenith Alpha™ Thoracic Endovascular Graft – Proximal Component Zenith Alpha™ Thoracic Endovascular Graft – Distal Extension Zenith Alpha™ Thoracic Endovascular Graft – Distal Component Zenith Alpha™ Thoracic Endovascular Graft – Proximal Tapered Component Zenith Alpha® 2 Thoracic Endovascular Graft – Proximal Component Zenith Alpha® 2 Thoracic Endovascular Graft – Proximal Tapered Component Zenith Alpha® 2 Thoracic Endovascular Graft – Distal Extension Zenith Alpha® 2 Thoracic Endovascular Graft – Distal Component Sydney IVF Cryopreservation Kit Sydney IVF Thawing Kit Zilver 635 Vascular Self-Expanding Stent Zilver 635® Vascular Stent Zilver 518 Vascular Self-Expanding Stent Zilver 518® Vascular Stent Endovascular Dilator Dilator Sets Nylon Dilator Zilver® PTX® Drug-Eluting Peripheral Stent ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope ShortShot® Saeed Hemorrhoidial Multi-Band Ligator with TriView® Anoscope Cook Celect Platinum Vena Cava Filter set for Jugular Vein Appraoch COOK Sydney IVF Blastocyst Vitrification Kit COOK Sydney IVF Blastocyst Warming Kit Sentrus Bite Block Sydney IVF Egg/Embryo Solutions Zilver 635® Biliary Stent Zilver 518® Biliary Stent Zilver 518 Biliary Self-Expanding Stent ProFusion Therapeutic Infusion Needle Coaxial Interventional Needle COOK Test Tube Heater Disposable Stone Collector Sydney IVF Embryo Biopsy Medium Niti-S Esophageal Stent Double Lumen Ovum Aspiration Needle Sentrus Dual-End Cleaning Brush Sentrus Endoscope Transport Bag Duette® Multi-Band Mucosectomy Duette® Multi-Band Mucosectomy Device Sentrus Suction Tubing COOK IVF Sperm Solutions Sydney IVF Blastocyst Freeze/Thaw Kit Towako Transmyometrial Embryo Transfer Set Sydney IVF Blastocyst Cryopreservation Kit Sydney IVF Blastocyst Thawing Kit Otrieva Tapered Ovum Aspiration Needle COOK IVF Egg/Embryo Solutions ENFit connector Feeding Tube with ENFit Connection Cystotome Cystotome Cystoenterostomy Needle Knife Evolution® Biliary Stent System Uncovered Evolution® Biliary Controlled-Release Stent - Uncovered Compass BDS Biliary Stents Frova Intubating introducer Flipper® 35 Closure Detachable Coil Delivery System COOK IVF Freeze/Thaw Kits Bentley BeBack Crossing Catheter Heraeus Peripheral Guidewire Single Lumen Ovum Aspiration Needle Semi-automatic Biopsy-Needle Murdoch Mechanical Arm Nathanson Liver Retractor System COOK Vacuum Pump Sentrus Endoscopy Adapter Set Sentrus Auxiliary Water Jet Connector FormulaTM 414 RX Renal Ballon-Expandable Stent Disposable Grasping Forceps Pillsense Capsule Pillsense Receiver Adv Serenity 018 Sydney IVF Gamete Buffer Sentrus Medical Lubricating Jelly Marcon Colon Decompression Set Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System -Tapered Component Zenith® Dissection Endovascular Stent with the Z-Trak® Plus Introduction System Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System-Straight Component

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198