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FCS — Light, Catheter, Fiberoptic, Glass, Ureteral Class II

FDA Device Classification

Classification Details

Product Code
FCS
Device Class
Class II
Regulation Number
876.4020
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K151243stryker endoscopySTRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral August 20, 2015
K061548strykerSTRYKER URETERAL ILLUMINATION SYSTEM IVSeptember 28, 2006
K982542stryker endoscopySTRYKER URETERAL ILLUMINATOR SYSTEM IIISeptember 22, 1998
K943801rocket of londonURIGLOW TRANSILLUMINATING URETERIC STENT MODELAugust 15, 1995
K945088gabriel medicalGABRIEL URETERAL ILLUMINATOR SYSTEM IIFebruary 7, 1995
K941506apple medicalURETERAL ILLUMINATOROctober 5, 1994
K940019gabriel medicalGABRIEL URETERAL ILLUMINATOR SYSTEMMay 2, 1994
K923436cook urologicalILLUMINATED URETERAL CATHETERMarch 5, 1993
K874680laser peripheralsLASEGUIDE 600A, 600B, 400A, AND 400BMarch 23, 1988
K880071laserguideSURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USEMarch 22, 1988