Custom Medical Concepts, Inc.
Country not established
- Devices
- 1
What Custom Medical Concepts, Inc. makes
Custom Medical Concepts, Inc. manufactures the Spinal Cord Access Epidural Introducer System, a device designed for epidural catheter insertion in spinal procedures. This system is intended to facilitate precise and controlled access to the epidural space for pain management or anesthesia applications.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) clearance pathway. The manufacturer operates from the United States, where its products are subject to compliance with U.S. medical device regulations.
Catalogue
Spinal Cord Access Epidural Introducer System Ref K904380
510(k) 510(k)
Frequently asked questions
How many devices does Custom Medical Concepts, Inc. have in the registry?
The registry currently lists 1 device for Custom Medical Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Custom Medical Concepts, Inc.'s devices?
Among its 1 most recently registered device, Custom Medical Concepts, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Custom Medical Concepts, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Custom Medical Concepts, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Custom Medical Concepts, Inc. in the registry?
The most recently registered devices listed for Custom Medical Concepts, Inc. include SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM.