Surgitek

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K946296QUADRA-COIL URETERAL STENTMarch 6, 1995
K944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMFebruary 7, 1995
K943491RIGHT ANGLE UROLOGIC LASER FIBERAugust 5, 1994
K941952SURGITEK INFUSERMay 24, 1994
K933261GRASPING FORCEPSJanuary 11, 1994
K933260HELICAL STONE/FLATWIRE STONE BASKETSJanuary 11, 1994
K930733URETERAL STENTJuly 23, 1993
K930483URETERAL CATHETERJuly 16, 1993
K926344HYDROPHILIC COATED GUIDEWIREMarch 5, 1993
K920451ENDOTEK ULTRA SYSTEMSeptember 17, 1992
K922542GRASPING FORCEPSAugust 19, 1992
K904793SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)March 5, 1991
K904797SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)March 5, 1991
K905015SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICEDecember 28, 1990
K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSeptember 5, 1990
K894495SURGITEK(R) EXTERNAL FILL PORTJanuary 17, 1990
K891339IRRI-FLO IRRIGATION DELIVERY SYSTEMJune 2, 1989
K880660SURGITEK SUPER DOUBLE J URETERAL STENT KITApril 14, 1988
K875333SURGITEK NPT MONITORApril 13, 1988
K872353SURGITEK INFUSION STENT SYSTEM*September 16, 1987