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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Eyelid Spacer/Graft, Biologic | NXM | Class 2 | Ophthalmic | No | 2013-02-04 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2017-12-22 |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | Class 2 | Obstetrics/Gynecology | No | 2019-06-20 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2014-09-04 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2013-02-04 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2019-08-28 |
| Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | ODD | Class 2 | Gastroenterology, Urology | No | 2019-03-25 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2019-08-29 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-02-23 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2024-05-30 |
| Mesh, Surgical, Collagen, Large Abdominal Wall Defects | OXK | Class 2 | General, Plastic Surgery | No | 2016-08-18 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2019-12-03 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | PAG | Class 2 | General, Plastic Surgery | No | 2013-02-04 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2013-02-04 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2013-02-04 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2020-01-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-02-04 |
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2013-02-04 |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2018-12-14 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2007-11-27 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2018-05-21 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2013-02-04 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2019-01-08 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2019-09-23 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2017-10-18 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2019-01-16 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2013-02-04 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2018-01-15 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2019-09-06 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2017-12-22 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2023-12-10 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2019-09-09 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2016-12-14 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2013-02-04 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2007-06-18 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2020-01-15 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2018-12-24 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2019-01-10 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2016-01-27 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2013-02-04 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2018-12-24 |
| Dislodger, Stone, Biliary | LQR | Class 2 | Gastroenterology, Urology | No | 2019-07-17 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2019-09-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1997-01-21 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2004-10-25 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2013-02-04 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2020-01-28 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-02-26 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2019-06-20 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2024-08-29 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2017-12-22 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2013-02-04 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2019-02-04 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2019-04-11 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2015-03-05 |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | Class 2 | General, Plastic Surgery | No | 2017-02-03 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2013-02-04 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2014-03-05 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2017-01-06 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2013-02-04 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2014-03-05 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2024-08-29 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2019-05-28 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Lithotriptor, Biliary Mechanical | LQC | Class 2 | Gastroenterology, Urology | No | 2021-04-08 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2018-12-24 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2019-10-30 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2019-10-30 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Retrograde Intubation Set | QCX | Class 2 | Anesthesiology | No | 2019-02-20 |
| Needle, Emergency Airway | BWC | Class 2 | Anesthesiology | No | 2019-06-26 |
| Mesh, Surgical, Collagen, Fistula | OXN | Class 2 | General, Plastic Surgery | No | 2020-08-24 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2020-08-24 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2020-08-25 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-12-24 |
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