Dalim Surgnet Corporation
United StatesFDA applicant, unverified
Part of DalimsurgNET corporation
- Devices
- 2
What Dalim Surgnet Corporation makes
Dalim Surgnet Corporation manufactures endoscopic optical coherence tomography (OCT) systems, including the OCTO and OCTOTMPORT devices. These tools provide high-resolution imaging of internal tissue structures, primarily used in gastrointestinal and endoscopic procedures to assess mucosal layers and detect abnormalities.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
Octo Ref K100045
Regimes: 510(k) Registry: 510(k)Octotmport Ref K112196
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dalim Surgnet Corporation have in the registry?
The registry currently lists 2 devices for Dalim Surgnet Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dalim Surgnet Corporation's devices?
Among its 2 most recently registered devices, Dalim Surgnet Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Dalim Surgnet Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dalim Surgnet Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dalim Surgnet Corporation in the registry?
The most recently registered devices listed for Dalim Surgnet Corporation include OCTO and OCTOTMPORT.