# K183578: Torpedo Gelatin Foam

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Jun 18, 2019 after 179 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 K010026 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181021: EmboCube Embolization Gelatin, Biosphere Medical, S.A. (2018) Summary page 4.

## Indications for use
Intended Use: Torpedo Gelatin Foam is indicated for use in embolization of hypervascular tumors

Source page: https://510kreport.com/device/K183578
Methodology: https://510kreport.com/methodology