# K261488: OBSIDIO Conformable Embolic

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 24, 2026 after 79 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K961923 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242507: OBSIDIO™ Conformable Embolic, Boston Scientific (2024) Summary page 5.

## Indications for use
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of: • Hypervascular tumors • Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature

Source page: https://510kreport.com/device/K261488
Methodology: https://510kreport.com/methodology