# K143038: Gel-Block 10X embolization pledgets

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 20, 2014 after 29 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: 6 generations back to K010026 (2001). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113266: Gel-Block Embolization Pledgets, Vascular Solutions, Inc. (2012) Summary page 4.

## Most influential descendants
- K181021: EmboCube Embolization Gelatin (2018), 1 descendant of its own
- K183578: Torpedo Gelatin Foam (2019), 0 descendants of its own

## Indications for use
The Gel-Block 10x embolization pledgets is intended for use in the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K143038
Methodology: https://510kreport.com/methodology