Cortek Endoscopy, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cortek Endoscopy, Inc.” (first 2000, latest 2000), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Cortek Endoscopy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000199 | CORTEK MINI LAPAROSCOPE | HET | 2000-04-13 | 83 |
| K000198 | CORTEK ARTHROSCOPE | HRX | 2000-04-11 | 81 |
| K000202 | CORTEK LAPAROSCOPES | GCJ | 2000-03-31 | 70 |
| K000200 | CORTEK URETHEROSCOPE | FGB | 2000-03-03 | 42 |
| K000197 | CORTEK CYSTOSCOPE | FAJ | 2000-03-03 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Cortek Endoscopy, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cortek Endoscopy, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cortek Endoscopy, Inc.” (first 2000, latest 2000), across 5 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 Cortek Endoscopy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cortek Endoscopy, Inc. is 70 days.
Which FDA product codes appear under Cortek Endoscopy, Inc.?
The most frequent FDA product codes under this applicant name are FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FGB (Ureteroscope And Accessories, Flexible/Rigid, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Cortek Endoscopy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Cortek Endoscopy, Inc.'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.