FDA Registration Active 🇺🇸 United States

COOK INCORPORATED

Reg #: 1000393132 · FEI: 1000393132 · Expires 2026
Products
78
Proprietary Names
169
Establishment Types
4
Classifications
78

Registration Details

Registration Name
COOK INCORPORATED
Registration Number
1000393132
FEI Number
1000393132
Status
Active
Expiry Year
2026
Initial Importer
No
Address
6300 N. MATTHEWS DR.
City
ELLETTSVILLE
State
IN
ZIP
47429
Country
US

Regulatory Submissions

510(k) Number
K141148

Owner / Operator

Firm Name
COOK, INC.
Operator Number
1820334
Address
750 DANIELS WAY
City
Bloomington
State
IN
Postal Code
47404
Country
US

Products

Device Name Product Code
Prosthesis, Eyelid Spacer/Graft, Biologic NXM
Stents, Drains And Dilators For The Biliary Ducts FGE
Micromanipulators And Microinjectors, Assisted Reproduction MQJ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Mesh, Surgical FTM
Catheter, Ureteral, Gastro-Urology EYB
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
Endoscopic Access Overtube, Gastroenterology-Urology FED
Syringe, Irrigating (Non Dental) KYZ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
Snare, Flexible FDI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator PAG
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
Barrier, Animal Source, Intraoral NPL
Catheter, Embolectomy DXE
Transducer, Ultrasonic, Diagnostic ITX
Transducer, Ultrasonic JOP
Intracardiac Patch Or Pledget, Biologically Derived PSQ
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Device, Vascular, For Promoting Embolization KRD
Dilator, Vessel, For Percutaneous Catheterization DRE
Catheter, Assisted Reproduction MQF
Stent, Ureteral FAD
Cuff, Nerve JXI
Introducer, Catheter DYB
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Endoscopic Cytology Brush FDX
Dilator, Catheter, Ureteral EZN
Biopsy Needle FCG
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Wound Dressing With Animal-Derived Material(S) KGN
Wire, Guide, Catheter DQX
Dilator, Catheter GCC
Adaptor, Catheter GCE
Stylet, Catheter DRB
Catheter, Angioplasty, Peripheral, Transluminal LIT
Catheter, Urological KOD
Scissors, General, Surgical LRW
Dilator, Esophageal KNQ
Mesh, Surgical, Polymeric FTL
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Dislodger, Stone, Biliary LQR
Dislodger, Stone, Basket, Ureteral, Metal FFL
Instrument, Manual, Surgical, General Use MDM
Instrument, Surgical, Disposable KDC
Dura Substitute GXQ
Instruments, Surgical, Cardiovascular DWS
Powered Laser Surgical Instrument GEX
Catheter, Nephrostomy LJE
Endoscope Channel Accessory ODC
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
Endoscopic Guidewire, Gastroenterology-Urology OCY
Cannula, Manipulator/Injector, Uterine LKF
Catheter, Continuous Flush KRA
Accessory, Assisted Reproduction MQG
Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Tube, Gastro-Enterostomy KGC
Flowmeter, Blood, Cardiovascular DPW
Catheter, Irrigation GBX
Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
Microtools, Assisted Reproduction (Pipettes) MQH
Marker, Radiographic, Implantable NEU
Tube, Tracheal (W/Wo Connector) BTR
Stylet, Surgical, General & Plastic Surgery GAH
Lithotriptor, Biliary Mechanical LQC
Dilator, Urethral KOE
Endoscopic Irrigation/Suction System OCX
Bronchoscope (Flexible Or Rigid) EOQ
Forceps, Wire Holding HYA
Retrograde Intubation Set QCX
Needle, Emergency Airway BWC
Mesh, Surgical, Collagen, Fistula OXN
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
Forceps, Biopsy, Electric KGE
Instrument, Biopsy KNW

Proprietary Names

Flexipet, Adjustable Handle Set Replacement O-Ring Set Use With K-MPH-1000 Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating Dual Lumen Ureteral Access Catheter Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating Flexi-Tip® Dual Lumen Ureteral Access Catheter CRAMER ERCP CATHETER GLO-TIP ERCP CATHETER GLO-TIP II DOUBLE LUMEN ERCP CATHETER HUIBREGTSE-KATON ERCP CATHETER CLASSIC ERCP CATHETER HABER RAMP CATHETER FUSION GLO-TIP ERCP CATHETER GLO-TIP II DOUBLE LUMEN ANGLED ERCP CATHETER Surgisis and Surgisis ES 1,4 Layer Tissue Graft Entuit Secure Gastrointestinal Suture Anchor Set Entuit Secure Adjustable Gastrointestinal Suture Anchor Set Flexor Ureteral Access Sheath with AQ Hydrophilic Coating Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating Non-Toxic Syringe Vacuum Syringe Taylor Gel Adapter Biodesign Otologic Butterfly Graft Biodesign Hernia Graft Acusnare Polypectomy Snare Needle's Eye Snare Retrieval Set - 54cm Biodesign Additae Hiatal Hernia Graft CorMatrix Cor Patch Retracta Detachable Embolization Coil Soft-Pass Coaxial Insemination Catheter Shepard Intrauterine Insemination Catheter Insemi-Cath Ultrathane Endoureterotomy Stent Set Liver Access and Biopsy Needle Set Liver Access and Biopsy Needle Cook-Swartz Doppler Flow Probe Standard Cuff Cook-Swartz Doppler Flow Probe Long Cuff Safety Wire Guide Introducer Tri-Ex Extraction Balloon with Multiple Sizing Williams Cystoscopic Injection Needle ENT/Sinonasal Soehendra Biliary Dilation Catheter Cotton Graduated Biliary Dilation Catheter Acusnare Polypectomy Snare Soft FUSION CYTOLOGY BRUSH CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH Flexor, Shuttle - SL Introducer with Tuohy-Borst Sidearm Flexor, Tuohy-Borst Side-Arm Introducer Shuttle,-SL Zimmon Needle Knife Papillotome SureTome™ SW Sphincterotome with DomeTip Fusion QuattroExtraction Balloon CATHETER ACCESSORIES Liberator Beacon Tip Locking Stylet Stylet Wires Advance, 14LP Low Profile PTA Balloon Dilatation Catheter Micropuncture Pedal Access Set Silhouette Transitionless - with Nitinol Wire Guide and Hemostatic Valve Cotton Cannulatome II PC Double Lumen Sphincterotome Cannulatome II PC Lumen Sphincterotome Cannulatome II PC Double Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotomes Howell D.A.S.H. Direct Acess System Cotton Cannulatome II PC Protector Howell D.A.S.H. Sphincterotome DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME COTTON CANNULATOME D.A.S.H. Dome Tip Double Lumen Sphincterotome D.A.S.H. Pre-Loaded with Acrobat 2 Wire Guide D.A.S.H. Preloaded with Acrobat Wire Guide Tri-Tome PC Protector UTS PRECURVED ULTRA TAPER SPHINCTEROTOME Universal Active Cord Kumpe Access Catheter HERCULES 3 STAGE BALLOON ESOPHAGEAL HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL - PYLORIC - COLONIC DISPOSABLE VARICES INJECTOR ACUJECT VARIABLE INJECTION NEEDLE Pakter Curved Needle Set Nathanson Transcystic Bile Duct Stone Exploration Pack Wittich Nitinol Stone Basket Guardia Access Nano Embryo Transfer Catheter FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY SOFT WIRE BASKET MEMORY HARD WIRE BASKET THE WEB EXTRACTION BASKET Web II Memory Extraction Basket Memory Eight Wire Basket Memory II Double Lumen Baskets Memory Helical Stone Extractor Basket Lead Clippers Bulldog™ Lead Extender Sof-Grip Hemostat One-Tie™ Compression Coil Coil Expander Tesla BiCord Active Cord Teslatome Bipolar Sphincterotome Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Ultraxx Nephrostomy Balloon Set Ultraxx Nephrostomy Balloon Set with TFE Sheath SNAPLOC WIRE GUIDE LOCKING DEVICE Captura Mini Biopsy Forceps W/O Spike Captura Serrated Forceps W/O Spike Captura Biopsy Forceps without Spike Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip Fallopian Tube Catheterization Set TriForce Peripheral Crossing Set Rosch-Uchida Transjugular Liver Access Set Ring Transjugular Intrahepatic Access Set Needle Catheter Combination Stylet Catheter Combination Hiatal Hernia Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether Universa Firm Ureteral Stent Set with Hydrophilic Coating Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe Ultraxx Nephrostomy Balloon with TFE Sheath Initial Placement Gastrostomy Set Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet ECHOTIP ULTRA FIDUCIAL NEEDLE Marker, Radiographic, Implantable, Biopsy needle Frova Intubating Introducer with Rapi-Fit Adapters Frova Intubating Introducer with Stiffening Cannula Balloon Ureteral Dilator Set Balloon Ureteral Dilator Soehendra Lithotripsy Cable Fusion Omni-Tome Sphincterotome Fusion Omni-Tome Pre-Loaded Sphincterotome Fusion Pre-Loaded Omni-Tome Fusion Omni Pre-Loaded with Acrobat 2 Wire Guide Fusion Omni-Tome Pre-Loaded with Acrobat Wire Guide Fusion Omni-Tome Ureteral TFE Dilator Set Ureteral Dilator Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper Ureteral Dilator With AQ, Hydrophilic Coating Ureteral Dilator Set Dilators With AQ, Hydrophilic Coating Ureteral TFE Dilator Ureteral Dilator Set Glo-Tip® Spray Catheter Captura® Disposable Bronchoscope Biopsy Forceps Cook 810 Set Desilets-Hoffman Introducer Set Desilets-Hoffman Introducer Set With Radiopaque Band Roadrunner Biliary Wire Guide ACROBAT CALIBRATED TIP WIRE GUIDE FUSION WIRE GUIDE LOCKING DEVICE DELTA WIRE GUIDE TRACER METRO DIRECT WIRE GUIDE ACROBAT 2 CALIBRATED TIP WIRE GUIDE ROADRUNNER WIRE GUIDE UroStream Hydrophilic Wire Guide STANDARD WIRE GUIDE Black Silicone Filiform Double Pigtail Ureteral Stent Set Retrograde Intubation Set Emergency Transtracheal Airway Catheter ACCESSORY IRRIGATION ADAPTER Biodesign Tissue Graft Fortify TRG Tissue Repair Graft Soules Intrauterine Insemination Catheter Durasis Dural Graft Captura Hot Serrated Forceps w/o Spike Captura Hot Biopsy Forceps Osteo-Site® Bone Biopsy Needle Murphy M1M™ Osteo-Site® Bone Biopsy Needle Set Murphy M2™ Osteo-Site® Bone Biopsy Needle Murphy M2™ Osteo-Site® Bone Biopsy Needle

Establishment Types

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