# K192667: gel-e Flex+ gel OTC

- Pathway: 510(k) (Special)
- Applicant: Gel-E, Inc.
- Decided: Oct 25, 2019 after 30 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: 9 generations back to K896068 (1990). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182811: gel-e Flex+, Gel-E, Inc. (2019) Summary page 5.

## Indications for use
gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

Source page: https://510kreport.com/device/K192667
Methodology: https://510kreport.com/methodology