# K231877: NavaClick Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Lineage Biomedical, Inc.
- Decided: Nov 30, 2023 after 157 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980987 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171362: Merit Syringe, Merit Medical Systems, Inc. (2017) Summary page 4.

## Recalls of this device
- Jul 12, 2024 · Class III · Z-2535-2024: Incorrect GTIN number on carton.

## Indications for use
The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin’s approved labeling.

Source page: https://510kreport.com/device/K231877
Methodology: https://510kreport.com/methodology