Medical device manufacturer
Cook Urological, Inc.
Cook Urological, Inc. holds 104 FDA 510(k) clearances across 53 product codes. Median elapsed review time is 88 days. openFDA lists 6 recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 104
- Product codes
- 53
- Median review
- 88 days
- Recall records
- 6
How does FDA spell Cook Urological, Inc.?
FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Cook Urological, Inc. | device/recall | normalised |
| Cook Urological, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Cook Urological, Inc. file in?
53 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| KOD | Catheter, Urological | 6 | 87 days | |
| EZN | Dilator, Catheter, Ureteral | 5 | 76 days | |
| FAD | Stent, Ureteral | 5 | 107 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 88 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 5 | 231 days | |
| MQL | Media, Reproductive | 5 | 74 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 91 days | |
| LJE | Catheter, Nephrostomy | 4 | 62 days | |
| EZL | Catheter, Retention Type, Balloon | 3 | 114 days | |
| GEX | Powered Laser Surgical Instrument | 3 | 51 days | |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 3 | 281 days | |
| EYB | Catheter, Ureteral, Gastro-Urology | 2 | 20 days | |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 76 days | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 43 days | |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 108 days | |
| FHA | Clamp, Penile | 2 | 115 days | |
| HFC | Aspirator, Endocervical | 2 | 187 days | |
| HHO | Screw, Fibroid, Gynecological | 2 | 168 days | |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 2 | 88 days | |
| KOB | Catheter, Suprapubic (And Accessories) | 2 | 50 days | |
| KOE | Dilator, Urethral | 2 | 155 days | |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 87 days | |
| MQG | Accessory, Assisted Reproduction | 2 | 51 days | |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 30 days | |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 7 days |
Showing the 25 they file in most, of 53.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Cook Urological, Inc. had a recall?
openFDA lists 6 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1162-2007TerminatedEZB
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Z-0377-2007TerminatedFED
Lack of assurance of sterility, as the packages may not have been sealed.
Z-0674-06TerminatedFAD
Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
Z-1584-05TerminatedKOE
Mislabeled as to size.
Z-0554-03TerminatedEZN
Product is labeled sterile, but was not sterilized.
Showing the 5 most recently initiated of 6.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Cook Urological, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | KNA | 281 | |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | EZL | 114 | |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | KNA | 336 | |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | HFE | 108 | |
| K082536 | COOK WIRE GUIDES | OCY | 55 | |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | FBK | 43 | |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | GEX | 51 | |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | GEX | 42 | |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | FFS | 74 | |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | MQL | 92 |
Source: openFDA device/510k · retrieved
Watch what Cook Urological, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.