Accu-Line
Country not established
- Devices
- 4
What Accu-Line makes
Accu-Line manufactures surgical and procedural kits for gastrointestinal access, including jejunostomy sets for feeding tube placement, percutaneous introducer kits for minimally invasive procedures, and a surgical marker for anatomical guidance. The company also produces Accu-Flush, a device for flushing and maintaining patency in feeding tubes or drainage systems.
The portfolio includes Class I and Class II devices, with several authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory requirements and are intended for use in clinical settings within the United States.
Catalogue
Jejunostomy Kit Ref K831847
Regimes: 510(k) Registry: 510(k)Accu-Line Surgical Marker Ref K830298
Regimes: 510(k) Registry: 510(k)Percutaneous Introducer Kit Ref K831636
Regimes: 510(k) Registry: 510(k)Accu-Flush Ref K831637
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accu-Line have in the registry?
The registry currently lists 4 devices for Accu-Line. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accu-Line's devices?
Among its 4 most recently registered devices, Accu-Line has devices listed in FDA 510(k) (4 devices).
What risk classes do Accu-Line's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Accu-Line's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accu-Line in the registry?
The most recently registered devices listed for Accu-Line include JEJUNOSTOMY KIT, ACCU-LINE SURGICAL MARKER, PERCUTANEOUS INTRODUCER KIT and ACCU-FLUSH.