# K213385: GEM

- Pathway: 510(k) (Traditional)
- Applicant: Obsidio, Inc.
- Decided: Jul 1, 2022 after 261 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961923 (1996). 9 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K183120: EmboCube Embolization Gelatin, Biosphere Medical, S.A. (2019) Summary page 4.

## Most influential descendants
- K242507: OBSIDIO™ Conformable Embolic (2024), 2 descendants of its own
- K261488: OBSIDIO Conformable Embolic (2026), 0 descendants of its own
- K253376: OBSIDIO™ Conformable Embolic (M0013972101010) (2025), 0 descendants of its own

## Recalls of this device
- Feb 20, 2024 · Class I · Z-1374-2024: An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and 

## Indications for use
Obsidio GEM™ 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/K213385
Methodology: https://510kreport.com/methodology