# K945088: Gabriel Ureteral Illuminator System II

- Pathway: 510(k) (Traditional)
- Applicant: Gabriel Medical, Inc.
- Decided: Feb 7, 1995 after 113 days
- Product code: FCS (Light, Catheter, Fiberoptic, Glass, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982542: Stryker Ureteral Illuminator System Iii (1998), 36 descendants of its own
- K061548: Stryker Ureteral Illumination System IV (2006), 35 descendants of its own
- K151243: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (2015), 34 descendants of its own
- K182160: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (2018), 33 descendants of its own
- K202592: Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (2020), 26 descendants of its own

Source page: https://510kreport.com/device/K945088
Methodology: https://510kreport.com/methodology