Cook Ireland, Ltd.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Cook Ireland, Ltd.” (first 2005, latest 2026), plus 3 PMA and 1 De Novo decisions, across 18 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cook Medical, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 119 |
| 2013 | 2 | 258 |
| 2014 | 1 | 88 |
| 2015 | 0 | — |
| 2016 | 3 | 53 |
| 2017 | 4 | 72 |
| 2018 | 3 | 236 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 1 | 143 |
| 2023 | 1 | 60 |
| 2024 | 2 | 176 |
| 2025 | 0 | — |
| 2026 | 1 | 98 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cook Ireland, Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 10 | 10 |
| FCG | Biopsy Needle | 7 | 7 |
| ESW | Prosthesis, Esophageal | 3 | 3 |
| MUM | Stent, Metallic, Expandable, Duodenal | 2 | 2 |
| FAD | Stent, Ureteral | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 1 | 1 |
| FER | Anoscope And Accessories | 1 | 1 |
Plus 8 more product codes.
Review panels
- Gastroenterology and Urology (31)
- Cardiovascular (3)
- Ear, Nose and Throat (1)
- General and Plastic Surgery (1)
Most recent Cook Ireland, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | KTI | 2026-07-24 | 98 |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | FCG | 2024-07-29 | 90 |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | FGE | 2024-06-14 | 262 |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | FCG | 2023-05-30 | 60 |
| K213946 | Compass BDS Biliary Stent | FGE | 2022-05-09 | 143 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | FCG | 2021-05-20 | 90 |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | FGE | 2018-11-16 | 18 |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | FGE | 2018-03-09 | 246 |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | FGE | 2018-02-27 | 236 |
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | FEG | 2017-08-01 | 60 |
22 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200023 | PMA | Zilver Vena Venous Self-Expanding Stent | 2020-10-09 |
| DEN180062 | De Novo | Endoscopic Transhepatic Venous Access Needle | 2019-11-20 |
| P100022 | PMA | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | 2012-11-14 |
| P050017 | PMA | ZILVER VASCULAR STENT | 2006-06-26 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-01-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cook, Inc. (364 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Biotech, Inc. (47 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Medical (1 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
- Cook Corporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Ireland, Ltd.?
FDA lists 32 510(k) clearances under the applicant name “Cook Ireland, Ltd.” (first 2005, latest 2026), plus 3 PMA and 1 De Novo decisions, across 18 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cook Ireland, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Ireland, Ltd. is 90 days. Since 2017: 90 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cook Ireland, Ltd.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 10); FCG (Biopsy Needle, 7); ESW (Prosthesis, Esophageal, 3).
Next steps
- See all 32 Cook Ireland, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Cook Ireland, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.