OBAHumanitarian device exemption

Polymerizing, Neurovascular Embolization Material

Unknown

OBA is the FDA product code for Polymerizing, Neurovascular Embolization Material. FDA's definition for this code reads: "The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OBA
Device name: Polymerizing, Neurovascular Embolization Material
FDA definition: The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Sterigenics U.S., LLC

Recent clearances

Product code OBA

FDA records hold no clearances under product code OBA.

Recent recalls

Product code OBA

FDA records show no recalls under product code OBA.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)