Company ยท US
Cook Urological, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2011. Name variants (Inc, Corp, punctuation) are merged.
104510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZN | Dilator, Catheter, Ureteral | 7 |
| FAD | Stent, Ureteral | 6 |
| KOD | Catheter, Urological | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 5 |
| MQL | Media, Reproductive | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| LJE | Catheter, Nephrostomy | 4 |
| EZL | Catheter, Retention Type, Balloon | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 |
| GEX | Powered Laser Surgical Instrument | 3 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 3 |
| KOE | Dilator, Urethral | 3 |
| EYB | Catheter, Ureteral, Gastro-Urology | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 |
| FHA | Clamp, Penile | 2 |
| HFC | Aspirator, Endocervical | 2 |
| HHO | Screw, Fibroid, Gynecological | 2 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 2011 | K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) Cook Urological, Inc. | KNA |
| Oct 9, 2009 | K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER Cook Urological, Inc. | EZL |
| Sep 3, 2009 | K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 Cook Urological, Inc. | KNA |
| Nov 7, 2008 | K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER Cook Urological, Inc. | HFE |
| Oct 27, 2008 | K082536 | COOK WIRE GUIDES Cook Urological, Inc. | OCY |
| Sep 25, 2008 | K082319 | INJEKT FILIFORM INJECTION NEEDLE Cook Urological, Inc. | FBK |
| Apr 17, 2008 | K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W Cook Urological, Inc. | GEX |
| Jan 23, 2008 | K073496 | OPTILITE HOLMIUM LASER FIBERS Cook Urological, Inc. | GEX |
| Nov 20, 2007 | K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH Cook Urological, Inc. | FFS |
| Aug 17, 2006 | K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER Cook Urological, Inc. | MQL |
| Jun 29, 2006 | K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE Cook Urological, Inc. | PGK |
| Mar 31, 2005 | K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH Cook Urological, Inc. | FED |
| Oct 1, 2004 | K041062 | INTRAUTERINE VENOGRAM NEEDLE SET Cook Urological, Inc. | LKF |
| Apr 6, 2004 | K040127 | COOK URETERAL BALLOON DILATION CATHETER SET Cook Urological, Inc. | EZN |
| Mar 23, 2004 | K031304 | SYDNEY IVF PVP Cook Urological, Inc. | MQL |
| Jan 16, 2004 | K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. | MQH |
| Jan 16, 2004 | K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, Cook Urological, Inc. | MQH |
| Feb 27, 2003 | K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET Cook Urological, Inc. | LJE |
| Dec 20, 2002 | K023353 | SYDNEY IVF HYALURONIDASE Cook Urological, Inc. | MQL |
| Oct 25, 2002 | K022484 | COOK INJECTION NEEDLE Cook Urological, Inc. | FBK |
| Aug 12, 2002 | K022002 | SYDNEY IVF CULTURE OIL Cook Urological, Inc. | MQL |
| Feb 8, 2002 | K014160 | PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. | MQG |
| May 3, 2001 | K011157 | COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT Cook Urological, Inc. | MQL |
| Aug 30, 2000 | K000251 | SPECTRUM SILICONE FOLEY CATHETER Cook Urological, Inc. | MJC |
| Mar 1, 2000 | K994417 | OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING Cook Urological, Inc. | MQE |
| Oct 27, 1999 | K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR Cook Urological, Inc. | MQG |
| Mar 25, 1999 | K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C Cook Urological, Inc. | EZN |
| Apr 10, 1998 | K972647 | CO2 PNEUMO-DISSECTOR Cook Urological, Inc. | HET |
| Oct 10, 1997 | K972977 | INSULATOR WIRE GUIDE Cook Urological, Inc. | KNY |
| Mar 19, 1997 | K970041 | ASCEND BALLOON DAILATION CATHETER Cook Urological, Inc. | EZN |
| Oct 18, 1996 | K961904 | AQ HYDROPHILIC DILATORS Cook Urological, Inc. | KOE |
| Aug 29, 1996 | K960263 | CERVICAL MUCOUS ASPIRATION CATHETER Cook Urological, Inc. | HFC |
| Jul 24, 1996 | K961371 | SUBCUTANEOUS URINARY DIVERSON STENT SET Cook Urological, Inc. | FAD |
| Jul 18, 1996 | K961933 | CIRCLE NEPHROSTOMY CATHETER SET Cook Urological, Inc. | LJE |
| Jun 11, 1996 | K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS Cook Urological, Inc. | EYB |
| Jun 10, 1996 | K952513 | LESE STENTS SETS Cook Urological, Inc. | FAD |
| May 28, 1996 | K961446 | AQ HYDROPHILIC STENT Cook Urological, Inc. | FAD |
| May 14, 1996 | K960768 | LASER FIBER DELIVERY/CLEANING CATHETER Cook Urological, Inc. | GEX |
| Apr 29, 1996 | K954903 | PEDI VAGINAL ASPIRATOR Cook Urological, Inc. | HFC |
| Apr 15, 1996 | K960262 | CORING MORCELLATOR Cook Urological, Inc. | HET |
| Mar 15, 1996 | K960878 | MAHLER ABDOMINAL WALL ELEVATOR Cook Urological, Inc. | GCJ |
| Mar 14, 1996 | K960469 | DETECT CYTOLOGY BRUSH II Cook Urological, Inc. | HHT |
| Feb 26, 1996 | K955508 | ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET Cook Urological, Inc. | LKF |
| Jan 22, 1996 | K955618 | BIPOLAR CUTTER Cook Urological, Inc. | GEI |
| Jan 2, 1996 | K952527 | BALLOON UTERINE STENT Cook Urological, Inc. | KNA |
| Dec 19, 1995 | K954398 | INSEMI-CATH II Cook Urological, Inc. | MFD |
| Sep 28, 1995 | K940265 | PATTON LAPAROSCOPIC CATHETER INTRODUCER SET Cook Urological, Inc. | HET |
| Aug 18, 1995 | K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND Cook Urological, Inc. | KOB |
| May 25, 1995 | K951106 | SILICONE FOLEY CATHETER Cook Urological, Inc. | EZL |
| May 11, 1995 | K950714 | COOK INSEMINATION CUP Cook Urological, Inc. | HDR |
Newest 50 of 104.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2007 | Cook Urological, Inc. Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413. Terminated |
EZB | None listed |
| Jan 25, 2007 | Cook Urological, Inc. Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. Terminated |
FED | K043418 |
| Mar 23, 2006 | Cook Urological, Inc. Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540. Terminated |
FAD | None listed |
| Sep 24, 2005 | Cook Urological, Inc. Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. Terminated |
KOE | K811833 |
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 Terminated |
EZN | K990072 |
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 Terminated |
EZN | K990072 |