# K160096: InZone Detachment System

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Feb 19, 2016 after 31 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: 10 generations back to K951256 (1995). 36 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120816: Inzone Detachment System, Stryker (2012) Summary page 4.

## Most influential descendants
- K203625: Numen Coil Embolization System; NumenFR Detachment System (2021), 3 descendants of its own
- K232955: Numen Coil Embolization System; NumenFR Detachment System (2024), 2 descendants of its own
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System (2024), 1 descendant of its own
- K212455: InZone Detachment System (2021), 1 descendant of its own
- K192068: i-ED COIL (2020), 1 descendant of its own

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

Source page: https://510kreport.com/device/K160096
Methodology: https://510kreport.com/methodology