# K251832: InZone IST Detachment System; IZDS Connecting Cable

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Oct 17, 2025 after 123 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K951256 (1995). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212455: InZone Detachment System, Stryker Neurovascular (2021) Summary page 5.

## Indications for use
The InZone IST Detachment System is intended for use with all versions of Stryker Neurovascular embolization devices in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K251832
Methodology: https://510kreport.com/methodology