# K061548: Stryker Ureteral Illumination System IV

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Sep 28, 2006 after 115 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
Longest line of descent: 2 generations back to K945088 (1995). 2 ancestors in all.
35 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)
- K982542: Stryker Ureteral Illuminator System Iii, Stryker Endoscopy (1998) Summary page 1.

## Most influential descendants
- 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
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own

## Indications for use
The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038" guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

Source page: https://510kreport.com/device/K061548
Methodology: https://510kreport.com/methodology