Light, Catheter, Fiberoptic, Glass, Ureteral

Product Code: FCS

Gastroenterology/Urology General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.4020


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FCS

1759Light, Catheter, Fiberoptic, Glass, UreteralFiberoptic Light Ureteral Catheter.

Total Product Life Cycle (TPLC) Devices

1759Light, Catheter, Fiberoptic, Glass, UreteralFiberoptic Light Ureteral Catheter.

Pre-market Notifications for FCS

K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source And IRIS Ureteral Kit]Stryker Endoscopy
K061548STRYKER URETERAL ILLUMINATION SYSTEM IVSTRYKER CORP.
K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker Endoscopy
K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGABRIEL MEDICAL, INC.
K943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELROCKET OF LONDON, LTD.
K941506URETERAL ILLUMINATORAPPLE MEDICAL CORP.
K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGABRIEL MEDICAL, INC.
K923436ILLUMINATED URETERAL CATHETERCOOK UROLOGICAL, INC.
K880071SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USELASERGUIDE
K874680LASEGUIDE 600A, 600B, 400A, AND 400BLASER PERIPHERALS LLC.

Global Unique Device Identification Database

37613327061216Light, catheter, fiberoptic, glass, ureteral
00827002167476Light, catheter, fiberoptic, glass, ureteral
00827002167469Light, catheter, fiberoptic, glass, ureteral
00827002167452Light, catheter, fiberoptic, glass, ureteral
00827002167377Light, catheter, fiberoptic, glass, ureteral
00827002162624Light, catheter, fiberoptic, glass, ureteral
00827002161436Light, catheter, fiberoptic, glass, ureteral

Maude Adverse Events

KARL STORZ LIGHT CORDKARL STORZ ENDOVISION INC.2020-02-26
KARL STORZ LIGHTED URETERAL STENTKARL STORZ2020-02-26
KARL STORZ LIGHT CORDKARL STORZ ENDOSCOPY - AMERICA2020-02-04
KARL STORZ LIGHTED URETERAL STENTKARL STORZ ENDOSCOPY - AMERICA2020-02-04
ILLUMINATED URETER PROBEKARL STORZ SE & CO. KG2019-08-16
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2019-08-05
ILLUMINATED URETER PROBEKARL STORZ SE & CO. KG2019-01-31
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2018-12-01
ILLUMINATED URETER PROBEKARL STORZ SE & CO. KG2018-10-23
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2018-08-28
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2018-06-12
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2018-04-19
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2018-03-07
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-12-01
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2017-08-14
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-06-15
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-06-15
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-06-15
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-06-15
PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)STRYKER ENDOSCOPY-SAN JOSE2017-05-05
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2017-04-07
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-03-24
STRYKERT INFRAVISION URETERAL KITSTRYKER ENDOSCOPY2017-03-21
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-03-21
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-03-09
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-02-08
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INCORPORATED2017-01-19
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-01-13
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-01-13
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-01-13
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2017-01-13
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2016-11-14
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2016-08-02
BUSH URETERAL ILLUMINATING CATHETER SETCOOK INC2016-06-28
BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SETCOOK INC2015-08-31
COOK MEDICALCOOK MEDICAL INC.2015-08-12
BUSH SL URETERAL LIGHTED CATHETER SETCOOK MEDICAL2015-08-07
INFRAVISION UNIVERSAL URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2015-04-08
INFRAVISION UNIVERSAL URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2015-01-05
BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SETCOOK INC2014-11-07
BUSH URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL INC2013-05-17
BUSH URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL, INC.2012-09-21
BUSH URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL, INC.2012-08-21
BUSH SL URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL, INC.2012-08-17
BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL INC.2011-10-11
BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL INC2010-09-17
INFRAVISION UNIVERSAL URETERAL KITSTRYKER ENDOSCOPY SAN JOSE2010-02-05
BUSH URETERAL ILLUMINATING CATHETER SETCOOK UROLOGICAL, INC.2008-10-31
ROUND TIP URETHRAL CATHETERRUSCH MANUFACTURING (UK) LTD.1996-08-22

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