Light, Catheter, Fiberoptic, Glass, Ureteral
Gastroenterology, Urology · 21 CFR 876.4020
Recent MDR events
93 adverse event reports on file
- IRIS URETERAL KITJul 9, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00455
- IRIS URETERAL KITJun 29, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00416
- IRIS URETERAL KITMay 6, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00286
- IRIS URETERAL KITMar 3, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00137
- IRIS URETERAL KITDec 23, 2025MalfunctionStryker Endoscopy-san Jose0002936485-2025-01011
- IRIS URETERAL KITSep 11, 2025MalfunctionStryker Endoscopy-san Jose0002936485-2025-00782
- IRIS URETERAL KITMay 22, 2025MalfunctionStryker EndoscopyMW5170714
- IRIS URETERAL KITOct 24, 2024InjuryStryker Endoscopy-san Jose0002936485-2024-00719
- IRIS URETERAL KITApr 23, 2024MalfunctionStryker Endoscopy-san Jose0002936485-2024-00346
- IRIS URETERAL KITFeb 15, 2024MalfunctionStryker Endoscopy-san Jose0002936485-2024-00133
Event type breakdown
Recalls
3 recall events for this product code
- Cook Inc.TerminatedApr 19, 2017
Bush DL Ureteral Illuminating Catheter Set
Product may overheat, melt, and burn patient.
Z-1870-2017 · View FDA record ↗ - Stryker EndoscopyTerminatedSep 16, 2008
Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
Z-1866-2008 · View FDA record ↗ - Stryker EndoscopyTerminatedSep 16, 2008
Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fibero
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
Z-1867-2008 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
Stryker Endoscopy
SAN JOSE, CA, US
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Stryker Emea Supply Chain Services
Venlo Limburg, NL
Carestream Health, Inc.
Rochester, NY, US
Freudenberg Medical Ireland Limited
Leitrim, IE
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Sterigenics Uk Limited
Alfreton Derbyshire, GB
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Fong's Engineering & Manufacturing Private Limited
Singapore Central Singapore, SG
Cook Incorporated
Bloomington, IN, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
10 clearances for this product code
- Stryker EndoscopyAug 20, 2015
K151243 · STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- Stryker Corp.Sep 28, 2006
K061548 · STRYKER URETERAL ILLUMINATION SYSTEM IV
- Stryker EndoscopySep 22, 1998
K982542 · STRYKER URETERAL ILLUMINATOR SYSTEM III
- Rocket of London, Ltd.Aug 15, 1995
K943801 · URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
- Gabriel Medical, Inc.Feb 7, 1995
K945088 · GABRIEL URETERAL ILLUMINATOR SYSTEM II
- Apple Medical Corp.Oct 5, 1994
K941506 · URETERAL ILLUMINATOR
- Gabriel Medical, Inc.May 2, 1994
K940019 · GABRIEL URETERAL ILLUMINATOR SYSTEM
- Cook Urological, Inc.Mar 5, 1993
K923436 · ILLUMINATED URETERAL CATHETER