Cortek Endoscopy, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Cortek Endoscopy, Inc. makes
Cortek Endoscopy, Inc. manufactures diagnostic and surgical endoscopy devices, including cystoscopes for bladder examination, mini laparoscopes for minimally invasive abdominal procedures, standard laparoscopes for broader surgical applications, urethroscopes for urethral assessments, and arthroscopes for joint evaluations.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Cortek Cystoscope Ref K000197
Regimes: 510(k) Registry: 510(k)Cortek Mini Laparoscope Ref K000199
Regimes: 510(k) Registry: 510(k)Cortek Laparoscopes Ref K000202
Regimes: 510(k) Registry: 510(k)Cortek Uretheroscope Ref K000200
Regimes: 510(k) Registry: 510(k)Cortek Arthroscope Ref K000198
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cortek Endoscopy, Inc. have in the registry?
The registry currently lists 5 devices for Cortek Endoscopy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cortek Endoscopy, Inc.'s devices?
Among its 5 most recently registered devices, Cortek Endoscopy, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cortek Endoscopy, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cortek Endoscopy, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cortek Endoscopy, Inc. in the registry?
The most recently registered devices listed for Cortek Endoscopy, Inc. include CORTEK CYSTOSCOPE, CORTEK MINI LAPAROSCOPE, CORTEK LAPAROSCOPES and CORTEK URETHEROSCOPE.