# K982542: Stryker Ureteral Illuminator System Iii

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Sep 22, 1998 after 63 days
- Product code: FCS (Light, Catheter, Fiberoptic, Glass, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4020
- 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: 1 generation back to K945088 (1995). 1 ancestor in all.
36 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945088: Gabriel Ureteral Illuminator System II, Gabriel Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K210088: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (2021), 25 descendants of its own

## Recalls of this device
- May 9, 2008 · Not classified · Z-1866-2008: Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery

## Indications for use
The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the surgeon identify the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. As a general surgery transillumination device, the Stryker Ureteral Illuminator System III replaces and is substantially equivalent to existing predicate fiberoptic light ureteral catheter transillumination devices.

Source page: https://510kreport.com/device/K982542
Methodology: https://510kreport.com/methodology