# K233056: EpiZact

- Pathway: 510(k) (Traditional)
- Applicant: Guidestar Medical Devices
- Decided: Nov 2, 2023 after 38 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K182268 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192421: EpiFaith Syringe, Flat Medical Co., Ltd. (2019) Summary page 5.

## Indications for use
EpiZact is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Source page: https://510kreport.com/device/K233056
Methodology: https://510kreport.com/methodology