# K113266: Gel-Block Embolization Pledgets

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: May 14, 2012 after 192 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: 5 generations back to K010026 (2001). 12 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 1.
- K052742: Hepasphere Microspheres, Biosphere Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K143038: Gel-Block 10X embolization pledgets (2014), 2 descendants of its own
- K133237: Gel-Bead Embolization Spheres (2014), 2 descendants of its own
- K181021: EmboCube Embolization Gelatin (2018), 1 descendant of its own
- K181051: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm (2018), 1 descendant of its own
- K171946: Gel-Bead (2017), 1 descendant of its own

## Indications for use
The Gel-Block Embolization Pledgets are intended for use in embolization of hypervascularized tumors and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K113266
Methodology: https://510kreport.com/methodology