Cook Endoscopy: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Cook Endoscopy” (first 2006, latest 2020), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 152 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 161 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cook Endoscopy took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNQ | Dilator, Esophageal | 2 | 2 |
| FCG | Biopsy Needle | 1 | 1 |
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | 1 | 0 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Cook Endoscopy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192697 | Instinct Plus Endoscopic Clipping Device | PKL | 2020-03-05 | 161 |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | KNQ | 2009-09-25 | 242 |
| K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE | FCG | 2009-02-06 | 86 |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | KNQ | 2006-12-01 | 144 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020021 | PMA | WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER | 2003-08-01 |
Recalls
16 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2011-06-07.
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. (190 510(k)s)
- Cook Incorporated (174 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Ireland, Ltd. (33 510(k)s)
- Cook Biotech, Inc. (31 510(k)s)
- Cook Biotech Incorporated (16 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Endoscopy?
FDA lists 4 510(k) clearances under the applicant name “Cook Endoscopy” (first 2006, latest 2020), plus 1 PMA decision, across 4 product codes in 2 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 Endoscopy?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Endoscopy is 152 days.
Which FDA product codes appear under Cook Endoscopy?
The most frequent FDA product codes under this applicant name are KNQ (Dilator, Esophageal, 2); FCG (Biopsy Needle, 1); MVG (System, Laser, Fiber Optic, Photodynamic Therapy, 1).
Next steps
- See all 4 Cook Endoscopy clearances with predicates and recalls
- Run predicate analysis for product code KNQ, Cook Endoscopy'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.