Medical Device Manufacturer · US , Bloomington , IN

Cook Incorporated

175 submissions · 153 cleared · Since 2006
175
Total
153
Cleared
1
Denied

Cook Incorporated — FDA 510(k) Submissions

Cook Incorporated has submitted 175 FDA 510(k) premarket notifications since 2006, of which 153 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Introducer, Catheter, Wire, Guide, Catheter, Stent, Ureteral, Catheter, Intravascular, Diagnostic, Catheter, Nephrostomy . Use the specialty filter in the sidebar to narrow results.

175 devices
1–25 of 175
Nest VT Vitrification Device
K233177 · MQK Labware, Assisted... · Obstetrics & Gynecology
Mar 2024 162d
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · MMX Device, Percutaneous... · Cardiovascular
May 2023 293d
Bakri Essential Postpartum Balloon
K223098 · OQY Intrauterine Tamponade... · Obstetrics & Gynecology
Oct 2022 28d
Endovascular Dilator and Sets
K210734 · DRE Dilator, Vessel, For... · Cardiovascular
Apr 2021 26d
Extra Large Check-Flo Introducer
K203670 · DYB Introducer, Catheter · Cardiovascular
Feb 2021 62d
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Jan 2020 238d
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Dec 2019 252d
Lumax Guiding Catheter
K191163 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2019 225d
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
K193133 · JOH Tube Tracheostomy And... · Anesthesiology
Dec 2019 30d
McLean-Ring Enteral Feeding Tube Set
K190084 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Oct 2019 267d
UPJ Occlusion Balloon Catheter
K183323 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Aug 2019 248d
Roadrunner PC Wire Guide, Olcott Torque Device
K182985 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2019 266d
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Jul 2019 256d
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · KGC Tube, Gastro-enterostomy · Gastroenterology & Urology
Jun 2019 260d
Deflectable Brush Biopsy Set
K191485 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Jun 2019 22d
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Jun 2019 263d
Peel-Away Introducer
K182403 · FED Endoscopic Access... · Gastroenterology & Urology
May 2019 267d
Cook Unimpregnated Central Venous Catheter
K182252 · FOZ Catheter, Intravascular,... · General Hospital
May 2019 270d
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
K183035 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
May 2019 197d
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)
K191015 · MQF Catheter, Assisted... · Obstetrics & Gynecology
May 2019 30d
Brush Biopsy Set ; Deflectable Brush Biopsy Set
K182231 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
May 2019 257d
Multi-Sideport Catheter Infusion Set
K182071 · KRA Catheter, Continuous Flush · Cardiovascular
Apr 2019 267d
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971 · FAD Stent, Ureteral · Gastroenterology & Urology
Apr 2019 273d
Park Blade Septostomy Catheter
K182399 · DXF Catheter, Septostomy · Cardiovascular
Apr 2019 212d
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
K181770 · LKF Cannula,... · Obstetrics & Gynecology
Mar 2019 269d

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