Novare Surgical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Novare Surgical Systems, Inc. makes
Novare Surgical Systems, Inc. manufactures surgical clamps, anastomosis assist devices, and high-dexterity laparoscopic instruments. Their product line includes spring clips, jaw inserts for tissue manipulation, and systems designed for precise tissue approximation and sealing, such as the Endolink True Movement System.
All listed devices fall under FDA Class II regulation and are cleared via the 510(k) pathway. The company’s products are registered with the FDA under this framework, and the manufacturer is based in the United States.
Catalogue
Flexline Clamp Ref K010727
Regimes: 510(k) Registry: 510(k)Engage Jaw Inserts Ref K992980
Regimes: 510(k) Registry: 510(k)Enclose Ii Anastomosis Assist Device Ref K032589
Regimes: 510(k) Registry: 510(k)Enclose Anastomosis Assist Device Ref K023682
Regimes: 510(k) Registry: 510(k)Realhand High Dexterity Instruments Ref K072715
Regimes: 510(k) Registry: 510(k)Includer Clamp Ref K010694
Regimes: 510(k) Registry: 510(k)Softline Spring Clip Ref K000098
Regimes: 510(k) Registry: 510(k)Realhand High Dexterity (Hd) Instruments Ref K071488
Regimes: 510(k) Registry: 510(k)Endolink True Movement System Ref K043541
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novare Surgical Systems, Inc. have in the registry?
The registry currently lists 9 devices for Novare Surgical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novare Surgical Systems, Inc.'s devices?
Among its 9 most recently registered devices, Novare Surgical Systems, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Novare Surgical Systems, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Novare Surgical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novare Surgical Systems, Inc. in the registry?
The most recently registered devices listed for Novare Surgical Systems, Inc. include FLEXLINE CLAMP, ENGAGE JAW INSERTS, ENCLOSE II ANASTOMOSIS ASSIST DEVICE and ENCLOSE ANASTOMOSIS ASSIST DEVICE.