DeviceClearance

Product code PUU— Neurology

Comaneci, Comaneci Petit, Comaneci 17

Classification name
Temporary Coil Embolization Assist Device
Device class
Class 2
Regulation
21 CFR 882.5955
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.”

— U.S. Food and Drug Administration, device classification record for product code PUU under 21 CFR 882.5955, via openFDA

Market context for product code PUU

FDA has cleared 1 device under product code PUU, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PUU

Recent clearances under product code PUU

Data sourced from openFDA. This site is unofficial and independent of the FDA.