Cook Urological, Inc.
Medical device manufacturer in Spencer, IN.
104510(k) clearances
0PMA approvals
2recalls
Device types
- KOD Catheter, Urological 6
- HET Laparoscope, Gynecologic (And Accessories) 5
- FAD Stent, Ureteral 5
- GEI Electrosurgical, Cutting & Coagulation &… 5
- EZN Dilator, Catheter, Ureteral 5
- MQL Media, Reproductive 5
- GCJ Laparoscope, General & Plastic Surgery 4
- LJE Catheter, Nephrostomy 4
- EZL Catheter, Retention Type, Balloon 3
- KNA Instrument, Manual, Specialized… 3
- GEX Powered Laser Surgical Instrument 3
- KOA Surgical Instruments, G-U, Manual (And… 2
- FED Endoscopic Access Overtube, Gastroenterology… 2
- HHO Screw, Fibroid, Gynecological 2
- LKF Cannula, Manipulator/Injector, Uterine 2
- KOE Dilator, Urethral 2
- OCZ Endoscopic Grasping/Cutting Instrument… 2
- FHA Clamp, Penile 2
- HFC Aspirator, Endocervical 2
- KOB Catheter, Suprapubic (And Accessories) 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
| K060908 | Sonohysterography Biopsy DevicePGK · Traditional | 06/29/2006SE |
| K043418 | Cook Pediatric Flexor Ureteral Access ShealthFED · Traditional | 03/31/2005SE |
| K041062 | Intrauterine Venogram Needle SetLKF · Traditional | 10/01/2004SE |
| K040127 | Cook Ureteral Balloon Dilation Catheter SetEZN · Traditional | 04/06/2004SESK |
| K031304 | Sydney Ivf PVPMQL · Traditional | 03/23/2004SE |
| K033904 | Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)MQH · Special | 01/16/2004SE |
| K033903 | Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes…MQH · Special | 01/16/2004SE |
| K024050 | Cook Nephrostomy Dilation Balloon Catheter SetLJE · Traditional | 02/27/2003SE |
| K023353 | Sydney Ivf HyaluronidaseMQL · Traditional | 12/20/2002SE |
| K022484 | Cook Injection NeedleFBK · Traditional | 10/25/2002SE |
| K022002 | Sydney Ivf Culture OilMQL · Traditional | 08/12/2002SE |
| K014160 | Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)MQG · Traditional | 02/08/2002SE |
| K011157 | Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw KitMQL · Traditional | 05/03/2001SE |
| K000251 | Spectrum Silicone Foley CatheterMJC · Traditional | 08/30/2000SE |
| K994417 | Ovum Pick-Up Needles with Aq Coating, Aspiration Needles with Aq CoatingMQE · Traditional | 03/01/2000SE |
| K992070 | Cook Ultra Quiet Vacuum Pump & RegulatorMQG · Traditional | 10/27/1999SE |
| K990072 | Balloon Ureteral Dilators, Accent DG Balloon Ureteral Dilator Set, Ascend Balloon…EZN · Traditional | 03/25/1999SE |
| K972647 | CO2 Pneumo-DissectorHET · Traditional | 04/10/1998SE |
| K972977 | Insulator Wire GuideKNY · Traditional | 10/10/1997SE |
| K970041 | Ascend Balloon Dailation CatheterEZN · Traditional | 03/19/1997SE |
| K961904 | Aq Hydrophilic DilatorsKOE · Traditional | 10/18/1996SE |
| K960263 | Cervical Mucous Aspiration CatheterHFC · Traditional | 08/29/1996SE |
| K961371 | Subcutaneous Urinary Diverson Stent SetFAD · Traditional | 07/24/1996SE |
| K961933 | Circle Nephrostomy Catheter SetLJE · Traditional | 07/18/1996SE |
| K962004 | Aq Hydrophilic Urological CathetersEYB · Traditional | 06/11/1996SE |
| K952513 | Lese Stents SetsFAD · Traditional | 06/10/1996SE |
| K961446 | Aq Hydrophilic StentFAD · Traditional | 05/28/1996SE |
| K960768 | Laser Fiber Delivery/Cleaning CatheterGEX · Traditional | 05/14/1996SE |
| K954903 | Pedi Vaginal AspiratorHFC · Traditional | 04/29/1996SE |
| K960262 | Coring MorcellatorHET · Traditional | 04/15/1996SE |
| K960878 | Mahler Abdominal Wall ElevatorGCJ · Traditional | 03/15/1996SE |
| K960469 | Detect Cytology Brush IIHHT · Traditional | 03/14/1996SE |
| K955508 | Rosch -Thurmond Fallopian Tube Catheterization SetLKF · Traditional | 02/26/1996SE |
| K955618 | Bipolar CutterGEI · Traditional | 01/22/1996SE |
| K952527 | Balloon Uterine StentKNA · Traditional | 01/02/1996SE |
| K954398 | Insemi-Cath IIMFD · Traditional | 12/19/1995SE |
| K940265 | Patton Laparoscopic Catheter Introducer SetHET · Traditional | 09/28/1995SE |
| K953024 | Lindner/Golomb SP Introducing SoundKOB · Traditional | 08/18/1995SE |
| K951106 | Silicone Foley CatheterEZL · Traditional | 05/25/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | 05/11/1995SE |
| K950776 | Bipolar SnareGAE · Traditional | 04/18/1995SE |
| K950810 | Rutner Biopsy DeviceFCG · Traditional | 03/06/1995SE |
| K930731 | Slip-Coat StentsFAD · Traditional | 12/08/1994SE |
| K944303 | Cook Urological Laparoscopic Trocar CleanerGCJ · Traditional | 12/02/1994SE |
| K944818 | Cook Aspiration/Irrigation UnitBTA · Traditional | 11/08/1994SE |
| K933842 | Klein Rectal Tampnade BalloonKNT · Traditional | 09/29/1994SE |
| K943231 | Bioplar ForcepsGEI · Traditional | 07/26/1994SE |
| K941528 | Pearl Packing ForcepsHCZ · Traditional | 05/12/1994SE |
| K935754 | Murdoch Intraoperative Laparoscopic Lens CleanerGCJ · Traditional | 05/02/1994SE |
| K930344 | Silicone Foley CatheterEZL · Traditional | 04/15/1994SE |
| K934451 | Hasson 360 Series Endoscopic Grasping ForcepsHET · Traditional | 03/17/1994SE |
| K933698 | 100 Series Endoscopic Grasping ForcepsHET · Traditional | 03/17/1994SE |
| K936026 | Cook Laparoscopic Mini Retractor SetHFI · Traditional | 03/11/1994SE |
| K935874 | Cook Coagulator ProbeGEI · Traditional | 03/07/1994SE |
| K931195 | Percutaneous Drainage Loop Catheter SetKOD · Traditional | 12/22/1993SE |
| K923729 | Ureteral CatheterEYB · Traditional | 12/07/1993SE |
| K933957 | Dilating Urethral SoundFAH · Traditional | 11/17/1993SE |
| K930135 | Silicone Rectal BalloonFEN · Traditional | 10/08/1993SE |
| K930608 | Onik-Cohen Access SetKOD · Traditional | 07/09/1993SE |
| K921546 | Vasovasostomy SetKOA · Traditional | 07/02/1993SESK |
| K923031 | EndosnareFDI · Traditional | 06/07/1993SE |
| K925851 | Cook Tissue MorcellatorGEI · Traditional | 05/21/1993SE |
| K923436 | Illuminated Ureteral CatheterFCS · Traditional | 03/05/1993SE |
| K925565 | Magnetic RetrieverGCJ · Traditional | 02/23/1993SE |
| K915209 | Malecot-Nephrostomy Tamponade CatheterLJE · Traditional | 11/10/1992SE |
| K922192 | Vas DilatorKOA · Traditional | 08/07/1992SE |
| K921120 | Flexible Cystoscopy Introducing CatheterFED · Traditional | 08/04/1992SE |
| K914692 | Urinary Diversion Evacuating CatheterEXD · Traditional | 07/02/1992SE |
| K915412 | Hysteroscopic Myoma ScrewHHO · Traditional | 05/18/1992SE |
| K915388 | Laparocopic Myoma ScrewHHO · Traditional | 05/18/1992SE |
| K915392 | Accent DG Balloon Urteral Dilator Set, 10CMEZN · Traditional | 03/18/1992SE |
| K915443 | Urodynamic CatheterFAP · Traditional | 02/19/1992SE |
| K912851 | Naude Urethral StentKOD · Traditional | 01/30/1992SE |
| K914280 | Echosight Stent SetFAD · Traditional | 01/09/1992SE |
| K912451 | Urodynamic Rectal BalloonFAP · Traditional | 12/02/1991SE |
| K910939 | Cook Tissue MorcellatorGEI · Traditional | 06/28/1991SE |
| K910876 | Autocath(Tm) SetGBM · Traditional | 05/28/1991SE |
| K905375 | Accent DG Balloon Ureteral Dilator SetEZN · Traditional | 04/12/1991SE |
| K910914 | Surgical Tissue PouchKGY · Traditional | 03/28/1991SE |
| K902695 | Disposable Inflation GaugeMAV · Traditional | 12/03/1990SE |
| K896160 | Williams Penile Anesthetic RetainerFHA · Traditional | 02/16/1990SE |
| K892855 | Urethral Balloon Dilation Catheter SetKOE · Traditional | 11/17/1989SE |
| K891406 | Balloon (Nephrostomy Tract) Dilation Catheter SetLJE · Traditional | 04/07/1989SE |
| K880748 | Ball Tip Fulgurating Electrode, 3 FrenchKNS · Traditional | 08/04/1988SE |
| K883119 | Vpi Non-Adhesive Condom CatheterEYT · Traditional | 08/02/1988SE |
| K881399 | 3 French Flexible Biopsy ForcepsOCZ · Traditional | 04/11/1988SE |
| K880100 | Cook Urological Wire Guide W/Hydromer CoatingKOD · Traditional | 03/15/1988SE |
| K870355 | (Ureteroscopic) Stricture Scapel or KnifeOCZ · Traditional | 04/01/1987SE |
| K863227 | Cook-Vpi Continence CuffFHA · Traditional | 02/03/1987SE |
| K863082 | Cook-Vpi Intermittent CatheterKOD · Traditional | 11/07/1986SE |
| K863385 | (Roth)Spiral Rotating Prostatic Biopsy NeedleKNN · Traditional | 11/04/1986SE |
| K863354 | Bio-Guard AB Coated CatheterKOD · Traditional | 11/04/1986SE |
| K863120 | (Stamey) T.U.R.P. Suprapubic Catheter SetKOB · Traditional | 10/24/1986SE |
| K863081 | 4-WIRE (Carson) Stone ExtractorFFL · Traditional | 10/24/1986SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1162-2007 | Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal…Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been… | 06/12/2007Terminated |
| Z-0377-2007 | Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF…Lack of assurance of sterility, as the packages may not have been sealed. | 01/05/2007Terminated |