Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cook Urological, Inc. — Predicate Candidate Screening
104 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
334 days90th percentile
104clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET | Cook Urological, Inc. | 2011-05-06 | 281 | 0 |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Cook Urological, Inc. | 2009-10-09 | 114 | 0 |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Cook Urological, Inc. | 2009-09-03 | 336 | 0 |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | 2008-11-07 | 108 | 1 |
| K082536 | COOK WIRE GUIDES | Cook Urological, Inc. | 2008-10-27 | 55 | 1 |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Cook Urological, Inc. | 2008-09-25 | 43 | 0 |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Cook Urological, Inc. | 2008-04-17 | 51 | 0 |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Cook Urological, Inc. | 2008-01-23 | 42 | 0 |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Cook Urological, Inc. | 2007-11-20 | 74 | 1 |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Cook Urological, Inc. | 2006-08-17 | 92 | 0 |
| K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE | Cook Urological, Inc. | 2006-06-29 | 87 | 0 |
| K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH | Cook Urological, Inc. | 2005-03-31 | 108 | 1 |
| K041062 | INTRAUTERINE VENOGRAM NEEDLE SET | Cook Urological, Inc. | 2004-10-01 | 161 | 0 |
| K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 2004-04-06 | 76 | 0 |
| K031304 | SYDNEY IVF PVP | Cook Urological, Inc. | 2004-03-23 | 334 | 0 |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES | Cook Urological, Inc. | 2004-01-16 | 30 | 0 |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MIC | Cook Urological, Inc. | 2004-01-16 | 30 | 0 |
| K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | Cook Urological, Inc. | 2003-02-27 | 80 | 2 |
| K023353 | SYDNEY IVF HYALURONIDASE | Cook Urological, Inc. | 2002-12-20 | 74 | 0 |
| K022484 | COOK INJECTION NEEDLE | Cook Urological, Inc. | 2002-10-25 | 88 | 0 |
| K022002 | SYDNEY IVF CULTURE OIL | Cook Urological, Inc. | 2002-08-12 | 54 | 1 |
| K014160 | PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIP | Cook Urological, Inc. | 2002-02-08 | 51 | 0 |
| K011157 | COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT | Cook Urological, Inc. | 2001-05-03 | 17 | 0 |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | 2000-08-30 | 216 | 0 |
| K994417 | OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WIT | Cook Urological, Inc. | 2000-03-01 | 63 | 0 |
| K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR | Cook Urological, Inc. | 1999-10-27 | 131 | 0 |
| K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATO | Cook Urological, Inc. | 1999-03-25 | 73 | 2 |
| K972647 | CO2 PNEUMO-DISSECTOR | Cook Urological, Inc. | 1998-04-10 | 269 | 0 |
| K972977 | INSULATOR WIRE GUIDE | Cook Urological, Inc. | 1997-10-10 | 60 | 0 |
| K970041 | ASCEND BALLOON DAILATION CATHETER | Cook Urological, Inc. | 1997-03-19 | 72 | 0 |
| K961904 | AQ HYDROPHILIC DILATORS | Cook Urological, Inc. | 1996-10-18 | 155 | 0 |
| K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | Cook Urological, Inc. | 1996-08-29 | 224 | 0 |
| K961371 | SUBCUTANEOUS URINARY DIVERSON STENT SET | Cook Urological, Inc. | 1996-07-24 | 106 | 0 |
| K961933 | CIRCLE NEPHROSTOMY CATHETER SET | Cook Urological, Inc. | 1996-07-18 | 62 | 0 |
| K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS | Cook Urological, Inc. | 1996-06-11 | 20 | 0 |
| K952513 | LESE STENTS SETS | Cook Urological, Inc. | 1996-06-10 | 377 | 0 |
| K961446 | AQ HYDROPHILIC STENT | Cook Urological, Inc. | 1996-05-28 | 42 | 17 |
| K960768 | LASER FIBER DELIVERY/CLEANING CATHETER | Cook Urological, Inc. | 1996-05-14 | 78 | 0 |
| K954903 | PEDI VAGINAL ASPIRATOR | Cook Urological, Inc. | 1996-04-29 | 187 | 0 |
| K960262 | CORING MORCELLATOR | Cook Urological, Inc. | 1996-04-15 | 88 | 0 |
| K960878 | MAHLER ABDOMINAL WALL ELEVATOR | Cook Urological, Inc. | 1996-03-15 | 11 | 0 |
| K960469 | DETECT CYTOLOGY BRUSH II | Cook Urological, Inc. | 1996-03-14 | 42 | 0 |
| K955508 | ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET | Cook Urological, Inc. | 1996-02-26 | 87 | 0 |
| K955618 | BIPOLAR CUTTER | Cook Urological, Inc. | 1996-01-22 | 42 | 0 |
| K952527 | BALLOON UTERINE STENT | Cook Urological, Inc. | 1996-01-02 | 215 | 0 |
| K954398 | INSEMI-CATH II | Cook Urological, Inc. | 1995-12-19 | 90 | 0 |
| K940265 | PATTON LAPAROSCOPIC CATHETER INTRODUCER SET | Cook Urological, Inc. | 1995-09-28 | 615 | 0 |
| K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND | Cook Urological, Inc. | 1995-08-18 | 50 | 0 |
| K951106 | SILICONE FOLEY CATHETER | Cook Urological, Inc. | 1995-05-25 | 76 | 0 |
| K950714 | COOK INSEMINATION CUP | Cook Urological, Inc. | 1995-05-11 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda