Cook Urological, Inc.: FDA clearances and approvals
Cook Urological, Inc. has 104 FDA 510(k) clearances (first 1986, latest 2011), across 53 product codes in 5 review panels. Median 510(k) review time: 89 days. openFDA lists 6 product recalls by a recalling firm named Cook Urological, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KOD | Catheter, Urological | 6 | 6 |
| EZN | Dilator, Catheter, Ureteral | 5 | 5 |
| FAD | Stent, Ureteral | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 5 | 5 |
| MQL | Media, Reproductive | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| LJE | Catheter, Nephrostomy | 4 | 4 |
| EZL | Catheter, Retention Type, Balloon | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
Plus 43 more product codes.
Review panels
- Gastroenterology and Urology (56)
- Obstetrics and Gynecology (31)
- General and Plastic Surgery (15)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent Cook Urological, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | KNA | 2011-05-06 | 281 |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | EZL | 2009-10-09 | 114 |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | KNA | 2009-09-03 | 336 |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | HFE | 2008-11-07 | 108 |
| K082536 | COOK WIRE GUIDES | OCY | 2008-10-27 | 55 |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | FBK | 2008-09-25 | 43 |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | GEX | 2008-04-17 | 51 |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | GEX | 2008-01-23 | 42 |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | FFS | 2007-11-20 | 74 |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | MQL | 2006-08-17 | 92 |
94 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2007-06-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cook Urological, Inc. have?
Cook Urological, Inc. has 104 FDA 510(k) clearances (first 1986, latest 2011), across 53 product codes in 5 review panels.
How long does FDA take to clear Cook Urological, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cook Urological, Inc.'s cleared 510(k)s is 89 days.
What devices does Cook Urological, Inc. make?
Its most frequent FDA product codes are KOD (Catheter, Urological, 6); EZN (Dilator, Catheter, Ureteral, 5); FAD (Stent, Ureteral, 5).
Has Cook Urological, Inc. had device recalls?
openFDA lists 6 product recalls in 5 recall events by a recalling firm whose name matches Cook Urological, Inc; the most recent began 2007-06-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 104 Cook Urological, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOD, Cook Urological, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.