Envision, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Envision, Inc. makes
Envision, Inc. manufactures sterile, single-use surgical packs designed for orthopedic procedures, including the ENVISION G31 P.E. PAK and ENVISION G21 I/A ENPAK, which are intended for use in joint replacement surgeries.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is based in the United States.
Catalogue
Envision G31 P.E. Pak Ref K832424
Regimes: 510(k) Registry: 510(k)Envision G21 I/A Enpak Ref K832423
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Envision, Inc. have in the registry?
The registry currently lists 2 devices for Envision, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Envision, Inc.'s devices?
Among its 2 most recently registered devices, Envision, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Envision, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Envision, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Envision, Inc. in the registry?
The most recently registered devices listed for Envision, Inc. include ENVISION G31 P.E. PAK and ENVISION G21 I/A ENPAK.