# K242507: OBSIDIO™ Conformable Embolic

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Oct 3, 2024 after 42 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: 7 generations back to K961923 (1996). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213385: GEM, Obsidio, Inc. (2022) Summary page 5.

## Most influential descendants
- K261488: OBSIDIO Conformable Embolic (2026), 0 descendants of its own
- K253376: OBSIDIO™ Conformable Embolic (M0013972101010) (2025), 0 descendants of its own

## Indications for use
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/K242507
Methodology: https://510kreport.com/methodology