# K180152: gel-e Flex

- Pathway: 510(k) (Traditional)
- Applicant: Gel-E, Inc.
- Decided: Jun 22, 2018 after 154 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- 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 K972914 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc, Hem Con Medical Technologies, Inc. (2008) Summary page 5.

## Most influential descendants
- K213652: Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (2023), 1 descendant of its own
- K253609: TRAUMAGEL® 2.0 Hemostatic Gel (2025), 0 descendants of its own

## Indications for use
gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.

Source page: https://510kreport.com/device/K180152
Methodology: https://510kreport.com/methodology