Genii, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Genii, Inc. makes
Genii, Inc. manufactures electrosurgical devices, including the GI 4000 Electrosurgical Generator and the ARC Smart Argon Probe, which are used in surgical procedures for tissue cutting and coagulation.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Genii Gi 4000 Electrosugical Generator Ref K113265
Regimes: 510(k) Registry: 510(k)Genii Arc Smart Argon Probe Ref K130983
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genii, Inc. have in the registry?
The registry currently lists 2 devices for Genii, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genii, Inc.'s devices?
Among its 2 most recently registered devices, Genii, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genii, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genii, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genii, Inc. in the registry?
The most recently registered devices listed for Genii, Inc. include GENII GI 4000 ELECTROSUGICAL GENERATOR and GENII ARC SMART ARGON PROBE.