Innerspace, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Innerspace, Inc. makes
Innerspace, Inc. manufactures intracranial pressure (ICP) monitoring systems, ventricular catheters, and subdural drainage devices. The SYNERGY system and ACTI-ICP monitoring system provide real-time ICP measurement, while the ACT series (ACT II, ACT III, ACT 11 MP) includes ventricular catheters for cerebrospinal fluid drainage. The MPS and MPS-T systems, along with the MPS Oxiport and Oxiport Plus, support intracranial oxygen monitoring. Subdural drainage and ICP-only devices include the Hummingbird H900DS and H800S.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. Innerspace, Inc. is based in the United States.
Catalogue
Synergy Ref K083378
Regimes: 510(k) Registry: 510(k)Acti-Icp Monitoring System Ref K003905
Regimes: 510(k) Registry: 510(k)Act 11 Mp Ventricular Catheter Ref K013005
Regimes: 510(k) Registry: 510(k)Mps Oxiport And Mps Oxiport Plus Ref K072379
Regimes: 510(k) Registry: 510(k)Mps (Or Mps-T) Ref K041838
Regimes: 510(k) Registry: 510(k)Act Iii Ventricular Catheter Ref K013705
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innerspace, Inc. have in the registry?
The registry currently lists 8 devices for Innerspace, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innerspace, Inc.'s devices?
Among its 8 most recently registered devices, Innerspace, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Innerspace, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Innerspace, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innerspace, Inc. in the registry?
The most recently registered devices listed for Innerspace, Inc. include SYNERGY, ACTI-ICP MONITORING SYSTEM, ACT 11 MP VENTRICULAR CATHETER and MPS OXIPORT AND MPS OXIPORT PLUS.