# K233069: Removal System Large Bore 60 cc Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Mar 26, 2024 after 182 days
- Product code: PUR (Vacuum Syringe)
- 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: 4 generations back to K980580 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163597: VacLok AT Vacuum Syringe, Merit Medical Systems, Inc. (2017) Summary page 4.

## Indications for use
The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.

Source page: https://510kreport.com/device/K233069
Methodology: https://510kreport.com/methodology